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Helmut Sitter


sitter@med.uni-marburg.de

Journal articles

2010
Cathleen Muche-Borowski, Matthias Kopp, Imke Reese, Helmut Sitter, Thomas Werfel, Torsten Schäfer (2010)  Allergy prevention.   J Dtsch Dermatol Ges 8: 9. 718-724 Sep  
Abstract: The further increase of allergies in industrialized countries demands evidence-based measures of primary prevention. The recommendations as published in the guideline of 2004 were updated and consented on the basis of a systematic literature search. Evidence from the period February 2003-May 2008 was searched in the electronic databases Cochrane and MEDLINE as well as in reference lists of recent reviews and by contacting experts. The retrieved citations were screened for relevance first by title and abstract and in a second step as full paper. Levels of evidence were assigned to each included study and the methodological quality of the studies was assessed as high or low. Finally the revised recommendations were formally consented (nominal group process) by representatives of relevant societies and organizations including a self-help group. Of originally 4556 hits, 217 studies (4 Cochrane Reviews, 14 meta-analyses, 19 randomized controlled trials, 135 cohort and 45 case-control studies) were included and critically appraised. Grossly unchanged remained the recommendations on avoiding environmental tobacco smoke, breast-feeding over 4 months (alternatively hypoallergenic formulas for children at risk), avoiding a mold-promoting indoor climate, vaccination according to current recommendations, and avoidance of furry pets (especially cats) in children at risk. The recommendation on reducing the house dust mite allergen exposure as a measure of primary prevention was omitted and the impact of a delayed introduction of supplementary food was reduced. New recommendations were adopted concerning fish consumption (during pregnancy / breast-feeding and as supplementary food in the first year), avoidance of overweight, and reducing the exposure to indoor and outdoor air pollutants. The revision of this guideline on a profound evidence basis led to (1) a confirmation of existing recommendations, (2) substantial revisions, and (3) new recommendations. Thereby it is possible to give evidence-based and up-to-date recommendations on primary prevention of allergies.
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P Kardos, H Berck, K - H Fuchs, A Gillissen, L Klimek, H Morr, D Pfeiffer-Kascha, G Schultze-Werninghaus, H Sitter, T Voshaar, H Worth (2010)  Guidelines of the German Respiratory Society for Diagnosis and Treatment of Adults Suffering from Acute or Chronic Cough.   Pneumologie Aug  
Abstract: The first set of German guidelines for diagnosis and treatment of patients suffering from acute or chronic cough was published in 2004. Scientific developments over the past five years necessitate an update.[nl]The purpose of this document is to assist in ascertaining underlying causes and treating cough, in order to eliminate or minimize impairments of patients' health.[nl]The guidelines aim to introduce scientifically founded, evidence-based steps for the diagnosis and treatment of cough and optimize cost-effectiveness. Recommendations are assessed through the GRADE system (The Grades of Recommendation, Assessment, Development and Evaluation).[nl]Cough as a symptom is categorized as either acute (lasting up to 8 weeks) or chronic (lasting more than 8 weeks) and attributed to distinct diseases. For acute and chronic cough the diagnostic algorithms are updated; cost effectiveness is also taken into account. Additionally, the most frequent diagnostic errors are highlighted. Finally, available therapeutic options are discussed.
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W Windisch, J Brambring, S Budweiser, D Dellweg, J Geiseler, F Gerhard, T Köhnlein, U Mellies, B Schönhofer, B Schucher, K Siemon, S Walterspacher, M Winterholler, H Sitter (2010)  Non-invasive and invasive mechanical ventilation for treatment of chronic respiratory failure. S2-Guidelines published by the German Medical Association of Pneumology and Ventilatory Support   Pneumologie 64: 4. 207-240 Apr  
Abstract: The field of mechanical ventilation is highly important in pulmonary medicine. The German Medical Association of Pneumology and Ventilatory Support ["Deutsche Gesellschaft für Pneumologie und Beatmungsmedizin e. V. (DGP)"] therefore has formulated these guidelines for home mechanical non-invasive and invasive ventilation. Non-invasive home mechanical ventilation can be administered using various facial masks; invasive home mechanical ventilation is performed via a tracheostomy. Home mechanical ventilation is widely and increasingly accepted as a treatment option for chronic ventilatory failure which most often occurs in COPD, restrictive lung diseases, obesity-hypoventilation syndrome and neuromuscular disorders. Essential for the initiation of home mechanical ventilation are the presence of symptoms of ventilatory failure and the detection of hypoventilation, most importantly hypercapnia. These guidelines comprise general indication criteria along with disease-specific criteria summarised by treatment algorithms. In addition, the management of bronchial secretions and care of paediatric patients are addressed. Home mechanical ventilation must be organised around a specialised respiratory care centre with expertise in patient selection, the initiation and the control of home mechanical ventilation. In this regard, the guidelines provide detailed information about technical requirements (equipment), control and settings of mechanical ventilation as well as organisation of patient care. A key requirement for home mechanical ventilation is the qualification of specialised home-care services, which is addressed in detail. Independent living and the quality of respiratory care are of highest priority in patients receiving home mechanical ventilation, since home mechanical ventilation can interfere with the integrity of a patient and often marks a life-sustaining therapy. Home mechanical ventilation has been shown to improve health-related quality of life of patients with chronic ventilatory failure. Long-term survival is improved in most patient groups, even though the long-term prognosis is often severely limited. For this reason, ethical issues regarding patient education, communication with ventilated patients at the end of life, living will, testament and medical care during the dying process are discussed.
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2009
Martin Henzel, Klaus Hamm, Helmut Sitter, Markus W Gross, Gunnar Surber, Gabriele Kleinert, Rita Engenhart-Cabillic (2009)  Comparison of stereotactic radiosurgery and fractionated stereotactic radiotherapy of acoustic neurinomas according to 3-D tumor volume shrinkage and quality of life.   Strahlenther Onkol 185: 9. 567-573 Sep  
Abstract: BACKGROUND AND PURPOSE: Stereotactic radiosurgery (SRS) and also fractionated stereotactic radiotherapy (SRT) offer high local control (LC) rates (> 90%). This study aimed to evaluate three-dimensional (3-D) tumor volume (TV) shrinkage and to assess quality of life (QoL) after SRS/SRT. PATIENTS AND METHODS: From 1999 to 2005, 35/74 patients were treated with SRS, and 39/74 with SRT. Median age was 60 years. Treatment was delivered by a linear accelerator. Median single dose was 13 Gy (SRS) or 54 Gy (SRT). Patients were followed up > or = 12 months after SRS/SRT. LC and toxicity were evaluated by clinical examinations and magnetic resonance imaging. 3-D TV shrinkage was evaluated with the planning system. QoL was assessed using the questionnaire Short Form-36. RESULTS: Median follow-up was 50/36 months (SRS/SRT). Actuarial 5-year freedom from progression/overall survival was 88.1%/100% (SRS), and 87.5%/87.2% (SRT). TV shrinkage was 15.1%/40.7% (SRS/SRT; p = 0.01). Single dose (< 13 Gy) was the only determinant factor for TV shrinkage after SRS (p = 0.001). Age, gender, initial TV, and previous operations did not affect TV shrinkage. Acute or late toxicity (> or = grade 3) was never seen. Concerning QoL, no significant differences were observed after SRS/SRT. Previous operations and gender did not affect QoL (p > 0.05). Compared with the German normal population, patients had worse values for all domains except for mental health. CONCLUSION: TV shrinkage was significantly higher after SRT than after SRS. Main symptoms were not affected by SRS/SRT. Retrospectively, QoL was neither affected by SRS nor by SRT.
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A Kadashchuk, S Schols, P Heremans, Yu Skryshevski, Yu Piryatinski, I Beinik, C Teichert, G Hernandez-Sosa, H Sitter, A Andreev, P Frank, A Winkler (2009)  Origin of the low-energy emission band in epitaxially grown para-sexiphenyl nanocrystallites.   J Chem Phys 130: 8. Feb  
Abstract: A comparative study of steady-state and time-resolved photoluminescence of para-sexiphenyl (PSP) films grown by organic molecular beam epitaxy (OMBE) and hot wall epitaxy (HWE) under comparable conditions is presented. Using different template substrates [mica(001) and KCl(001) surfaces] as well as different OMBE growth conditions has enabled us to vary greatly the morphology of the PSP crystallites while keeping their chemical structure virtually untouched. We prove that the broad redshifted emission band has a structure-related origin rather than being due to monomolecular oxidative defects. We conclude that the growth conditions and type of template substrate impacts substantially on the film morphology (measured by atomic force microscopy) and emission properties of the PSP films. The relative intensity of the defect emission band observed in the delayed spectra was found to correlate with the structural quality of PSP crystallites. In particular, the defect emission has been found to be drastically suppressed when (i) a KCl template substrate was used instead of mica in HWE-grown films, and (ii) in the OMBE-grown films dominated by growth mounds composed of upright standing molecules as opposed to the films consisting of crystallites formed by molecules lying parallel to the substrate.
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Cathleen Muche-Borowski, Matthias Kopp, Imke Reese, Helmut Sitter, Thomas Werfel, Torsten Schäfer (2009)  Allergy prevention.   Dtsch Arztebl Int 106: 39. 625-631 Sep  
Abstract: BACKGROUND: Evidence-based primary prevention of allergic conditions is important in view of their increasing prevalence in Western industrialized countries. METHODS: The Cochrane and Medline databases were searched for relevant scientific publications that appeared from February 2003 to May 2008. Articles in the reference lists of recent reviews were also considered, and experts were directly asked for their opinions. The retrieved publications were screened for relevance by evaluation of the title and abstract, and then by evaluation of the entire text. Each study chosen for inclusion was assigned an evidence grade as well as a grade for study quality relating to its potential for bias (low or high). The revised recommendations were then formally accepted by a consensus of representatives of medical specialist societies and other organizations, including a patient self-help group. RESULTS: The search initially yielded 4556 results out of which 217 articles (4 Cochrane reviews, 14 meta-analyses, 19 randomized clinical trials, 135 cohort studies, and 45 case-control studies) were chosen for inclusion and critical appraisal. No major changes ensued in the existing recommendations to avoid exposure to tobacco smoke, breast-feed for 4 months (or use hypoallergenic formulas), avoid a mould-promoting indoor climate, avoid exposure to furry pets (particularly cats), and vaccinate according to the current recommendations of the Standing Committee on Vaccination of the Robert Koch Institute (Ständige Impfkommission, STIKO). Neither the delayed introduction of solid food nor the avoidance of potent dietary allergens is recommended as a means of primary prevention. New recommendations were issued regarding fish consumption (by the mother while breastfeeding and nursing, and by the infant as solid food), avoidance of overweight, and reduction of exposure to air pollutants. CONCLUSIONS: This updated guideline serves as an aid in giving patients current, evidence-based recommendations for allergy prevention.
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2008
Maria-Anna LE Laekeman, Helmut Sitter, Heinz Dieter Basler (2008)  The Pain Attitudes and Beliefs Scale for Physiotherapists: psychometric properties of the German version.   Clin Rehabil 22: 6. 564-575 Jun  
Abstract: OBJECTIVES: To evaluate the psychometric properties of the German version of the Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT-G). The original Dutch version is a 36-item self-report scale discriminating between a biomedical and a biopsychosocial orientation of therapists with regard to low back pain management. METHODS: The German version was generated by use of a forward-backward translation procedure. In a cross-sectional study with a repeated measurement after five weeks, a total of 424 physiotherapists got a questionnaire package with the PABS-PT-G as well as the Tampa Scale of Kinesiophobia and patient vignettes. Item and factor analyses served to determine the psychometric properties of the scale. RESULTS: A total of 280 physiotherapists (response rate 79%) completed the questionnaires and a principal component analysis confirmed the two subscales of the original Dutch version. Internal consistency (Cronbach's alpha) of the items belonging to the biomedical factor amounted to 0.77 and to 0.58 for the items of the biopsychosocial factor respectively. Retest reliability showed a coefficient of 0.83 for the biomedical scale and of 0.70 for the biopsychosocial scale. Validity of both subscales of the PABS-PT-G was supported by statistically significant (P<0.01) and substantial correlations with the Tampa Scale of Kinesiophobia and with attitudes of the physiotherapists measured by patient vignettes (r between 0.37 and 0.72). CONCLUSION: The PABS-PT-G appears to be a reliable and valid instrument, which is equivalent to the original Dutch version. Further research is proposed to improve the reliability of the biopsychosocial subscale.
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Johannes T Heverhagen, Helmut Sitter, Andreas Zielke, Klaus J Klose (2008)  Prospective evaluation of the value of magnetic resonance imaging in suspected acute sigmoid diverticulitis.   Dis Colon Rectum 51: 12. 1810-1815 Dec  
Abstract: PURPOSE: The purpose of this study was to prospectively investigate patients with suspected acute colonic diverticulitis and to provide sensitivity, specificity, and interobserver agreement in a blinded trial. METHODS: Fifty-five patients (29 men; 59 +/- 13 (range, 29-76) years) who reported to the emergency room with clinically suspected acute colonic diverticulitis were prospectively included in the study. All patients underwent magnetic resonance imaging scans of their abdomen before and after contrast agent administration. Two assessors blinded to all clinical, laboratory, and radiologic results evaluated the images separately. RESULTS: The assessors reported colonic wall thickening, segmental narrowing of the colon, presence of diverticula, pericolic fatty infiltration, ascites, and abscesses. The assessors had to diagnose or rule out acute colonic diverticulitis. Sensitivities, specificities, positive, and negative likelihood ratios were derived. To determine interobserver agreement, a Cohen's kappa coefficient was calculated. The two assessors exhibited sensitivities of more than 94 percent, specificities of 88 percent, positive likelihood ratios of more than 7.5, and negative likelihood ratios of less than 0.07. The kappa coefficient showed a significant, strong correlation between both assessors (kappa = 0.68). CONCLUSIONS: Magnetic resonance imaging is investigator independent and provides high sensitivity and specificity for the diagnosis of acute colonic diverticulitis.
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B Schönhofer, R Kuhlen, P Neumann, M Westhoff, C Berndt, H Sitter (2008)  Non-invasive ventilation as treatment for acute respiratory insufficiency. Essentials from the new S3 guidelines   Anaesthesist 57: 11. 1091-1102 Nov  
Abstract: BACKGROUND: Scientific evidence is accumulating that non-invasive ventilation (NIV) may be beneficial for different patient groups with acute respiratory insufficiency (ARI). The aim of the new S3 guidelines is to propagate evidence-based knowledge about the indications and limitations of NIV in clinical practice. METHODS: A total of 28 experts from 12 German medical societies were involved in the process of development of the present guidelines. These experts systematically analyzed approximately 2,900 publications. Finally, the recommendations were discussed and approved in two consensus conferences. RESULTS: In hypercapnic ARI, NIV reduces the length of stay and mortality during intensive care treatment [grade A recommendation (A)]. Patients with cardiopulmonary edema should be treated with continuous positive airway pressure (CPAP) or NIV (A). For immunocompromized patients with ARI, NIV reduces the mortality (A). In patients with postextubation respiratory failure and during weaning from mechanical ventilation, NIV reduces the risk of reintubation (A). For patients who decline to be ventilated invasively, NIV may be an acceptable alternative (B). Non-invasive ventilation can also successfully be used in pediatric patients with ARI caused by different reasons (C). In acute respiratory distress syndrome (ARDS) NIV cannot generally be recommended because the failure rate is relatively high. CONCLUSION: Non-invasive ventilation is still not as widely implemented in clinical medicine as would be expected on the basis of the scientific literature. The aim of the present guidelines is to further propagate NIV for the treatment of ARI.
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Bernd Schönhofer, Ralf Kuhlen, Peter Neumann, Michael Westhoff, Christian Berndt, Helmut Sitter (2008)  Clinical practice guideline: non-invasive mechanical ventilation as treatment of acute respiratory failure.   Dtsch Arztebl Int 105: 24. 424-433 Jun  
Abstract: INTRODUCTION: Non-invasive mechanical ventilation (NIV) has been used to treat acute respiratory failure (ARF) for approximately 20 years. This guideline addresses the indications for, and limitations of, NIV as treatment for ARF according to evidence-based criteria. METHODS: A panel of experts from 12 scientific medical societies reviewed circa 2900 publications. The panel judged the clinical relevance of these studies and assessed the evidence presented in each, then held two interdisciplinary consensus conferences to formulate guideline recommendations and algorithms. RESULTS: Whenever possible, NIV should be preferred to invasive mechanical ventilation, in order to avoid the risk of ventilator and tube-associated complications such as nosocomial pneumonia (grade of recommendation A). Particularly in patients with hypercapnic ARF, NIV reduces the rate of hospital-acquired pneumonia, the length of hospital stay and mortality in the intensive care unit and in the hospital (grade of recommendation A). NIV (or continuous positive airway pressure) is also recommended in cardiogenic pulmonary edema (grade of recommendation A), as treatment for ARF in immunocompromised patients (grade of recommendation A), to prevent postextubation failure, to facilitate weaning in patients with hypercapnic ARF (grade of recommendation A), and to improve dyspnea in palliative care (grade of recommendation C). NIV is not generally recommended in patients with hypoxic ARF because of its high failure rate of 30% to over 50% in such patients. DISCUSSION: Although evidence indicates that NIV can be used as the treatment of first choice for several indications, it is still underutilized in the acute setting. These guidelines provide evidence-based information about the indications for, and limitations of, NIV in the treatment of ARF.
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2007
Artur Bauhofer, Ulrike Plaul, Alexander Torossian, Michael Koller, Benno Stinner, Ilhan Celik, Helmut Sitter, Bernd Greger, Martin Middeke, Moshe Schein, Jeremy Wyatt, Per-Olof Nyström, Thomas Hartung, Matthias Rothmund, Wilfried Lorenz (2007)  Perioperative prophylaxis with granulocyte colony-stimulating factor (G-CSF) in high-risk colorectal cancer patients for an improved recovery: A randomized, controlled trial.   Surgery 141: 4. 501-510 Apr  
Abstract: BACKGROUND: We aimed to improve the postoperative outcome of high-risk patients (American Society of Anesthesiologists class 3 and 4) recovering from colorectal cancer surgery by using recombinant human G-CSF (filgrastim) as perioperative prophylaxis. METHODS: In a double-blinded, placebo-controlled trial, 80 patients undergoing left-sided colorectal resection were randomized to filgrastim or placebo. Filgrastim (5 mug/kg) or placebo was administered in the afternoon on day -1, 0, and +1 relative to the operation. Primary endpoints were in a hierarchic order: quality of life (QoL) over time (determined at discharge, 2 and 6 months after operation with the European Organization for Research and Treatment of Cancer questionnaire) and the McPeek recovery score, which measures death and duration of stays in the intensive care unit and hospital. Predefined secondary endpoints were global QoL, subdomains of QoL, postoperative recovery, duration of stay, 6-month overall survival, complication rates, and cellular and immunologic parameters. RESULTS: There were no significant differences in both primary endpoints between the treatment groups. A significant improvement (P < .05) was obtained by filgrastim prophylaxis in the QoL subdomain family life /- social functioning,; thus, more patients recovered to their preoperative state (14 vs 4 with placebo) as determined by structured interviews. Duration of hospital stay (14 vs 12 days) and noninfectious complications were decreased from 8% to 3%. CONCLUSIONS: High-risk patients undergoing major operation for colorectal cancer profited from filgrastim prophylaxis with regard to duration of hospital stay, noninfectious complications, social QoL, and subjective recovery from operation. These endpoints, however, were secondary, and the primary endpoints (overall QoL and the McPeek index) did not show comparable benefits. A new confirmatory trial with the successful endpoints of this trial, as well as a cost analysis, will be needed to confirm the results before a general recommendation for the prophylactic use of G-CSF in high-risk cancer patients can be given.
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Martin Henzel, Klaus Hamm, Markus W Gross, Gunnar Surber, Gabriele Kleinert, Thomas Failing, Helmut Sitter, Gerd Strassmann, Rita Engenhart-Cabillic (2007)  Fractionated stereotactic radiotherapy of glomus jugulare tumors. Local control, toxicity, symptomatology, and quality of life.   Strahlenther Onkol 183: 10. 557-562 Oct  
Abstract: BACKGROUND AND PURPOSE: For glomus jugulare tumors, the goal of treatment is microsurgical excision. To minimize postoperative neurologic deficits, stereotactic radiosurgery (SRS) was performed as an alternative treatment option. Stereotactic fractionated radiotherapy (SRT) could be a further alternative. This study aims at the assessment of local control, side effects, and quality of life (QoL). PATIENTS AND METHODS: Between 1999-2005, 17 patients were treated with SRT. 11/17 underwent previous operations. 6/17 received primary SRT. Treatment was delivered by a linear accelerator with 6-MV photons. Median cumulative dose was 57.0 Gy. Local control, radiologic regression, toxicity, and symptomatology were evaluated half-yearly by clinical examination and MRI scans. QoL was assessed by Short Form-36 (SF-36). RESULTS: Median follow-up was 40 months. Freedom from progression and overall survival for 5 years were 100% and 93.8%. Radiologic regression was seen in 5/16 cases, 11/16 patients were stable. Median tumor shrinkage was 17.9% (p=0.14). Severe acute toxicity (grade 3-4) or any late toxicity was never seen. Main symptoms improved in 9/16 patients, 7/16 were stable. QoL was not affected in patients receiving primary SRT. CONCLUSION: SRT offers an additional treatment option of high efficacy with less side effects, especially in cases of large tumors, morbidity, or recurrences after incomplete resections.
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2006
B Dick, H Sitter, E Blau, N Lind, E Wege-Heuser, I Kopp (2006)  Clinical pathways in psychiatry and psychotherapy   Nervenarzt 77: 1. 12, 14-8, 20-2 Jan  
Abstract: BACKGROUND: Implementing evidence-based clinical guidelines by means of clinical pathways is one of the key elements of continuous quality management at the University Hospital of Marburg. This paper explains how clinical pathways for suicidal ideation and suicide attempts were developed. METHODS: Based upon a review of existing guidelines and literature, optimal standards of care were defined. Step-by-step analysis of the process of care and results of a questionnaire were used to describe the actual processes. A problem-orientated comparison of the actual and the optimal process of care was the basis for developing these pathways. A consensus was achieved with all persons involved in the respective process of care taking into consideration local resources as well as barriers. The most important decisions and interventions were defined and presented as a patient-oriented process. RESULTS: The lack of explicit "how to do it"-recommendations of the guidelines for the entire care processes required specific, locally tailored adaptations. Potentials for improvement were identified in the following areas: transfer of patients, consultation, information and coordination within the team, and diagnosis of suicide risk. The pathways include care-oriented algorithms, checklists and assignments of responsibility. CONCLUSIONS: The development of clinical pathways as part of quality management and transsectoral integrated care in psychiatry and psychotherapy is feasible. The concept presented incorporates the potential of increasing transparency, efficiency and efficacy of care, and of improving satisfaction of those involved. It offers psychiatric hospitals the chance to guarantee optimal quality of care in face of increasing workload and costs.
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Artur Bauhofer, Wilfried Lorenz, Michael Koller, Henrik Menke, Daniel I Sessler, Helmut Sitter, Ilhan Celik, Christoph Nies, Hinnerk Wulf, Alexander Torossian (2006)  Evaluation of the McPeek postoperative outcome score in three trials.   Langenbecks Arch Surg 391: 4. 418-427 Aug  
Abstract: BACKGROUND: Postoperative outcome of patients is determined by recovery characteristics and self-reported quality of life. The first can be assessed with the McPeek score which values three aspects of recovery: mortality, postoperative critical care and duration of hospitalization. MATERIALS AND METHODS: We calculated the McPeek score of 669 patients in three trials: (1) colorectal cancer surgery, (2) antihistamine/volume loading in various operations, and (3) cholecystectomy. Beforehand, the average of intensive care unit treatment and duration of hospitalization were determined for the different operations to define McPeek score points. The score was tested on reliability, validity, and sensitivity. In addition, clinical applicability was assessed in a survey. RESULTS: The score was reliable with similarly distributed score points in the three trials at different institutions. Inter-rater reliability was high (97% overlap). Validity was proven by moderate high correlation to convergent criteria such as complications (trial I to III r=0.43, r=0.38, r=0.60), preoperative American Society of Anesthesiologists class (ASA) (r=0.24, r=0.28, r=0.57), and age (r=0.23, r=0.32, r=0.31). The score was different between patients with and without neoplasms (P<0.001, trial II) and between elective or emergency patients (P<0.001, trial III). In a survey, investigators reported that the score was easy to assess and more comprehensive than four other scores. CONCLUSIONS: The McPeek score values the postoperative outcome on a nonlinear scale. A priori, the average duration of hospitalization and critical care for a specific operation has to be defined. Our validation suggests that it is a reliable, valid, sensitive, and practical instrument for outcome analysis after anesthesia and surgery.
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M Schnabel, S Sewtz, H Sitter, H - G Haaf, J Fischer (2006)  Development of a clinical guideline on medical rehabilitation of patients after lumbar disc surgery   Rehabilitation (Stuttg) 45: 4. 213-220 Aug  
Abstract: In cooperation with the Federation of German Pension Insurance Institutes (VDR) and with the VfR Norderney e. V., the university of Witten/Herdecke has developed a clinical guideline on medical rehabilitation for patients after lumbar disc surgery. Methodically, development of this guideline was based on the following three steps: (1) consideration of recent scientific literature, (2) analyses of structures and processes employed in rehab clinics, using consultations with clinic managers, with occupational groups involved in rehabilitation and analysis of patient files, as well as (3) the consensus process. One central result was the statement of substantial paucity of research on evidence for many therapeutic interventions used in orthopaedic rehabilitation of patients after lumbar disc surgery. Analyses and investigations in rehabilitation clinics showed a wide range of therapeutic interventions, used to very different extents. Development of the guideline therefore took place on the basis of consensus-based processes. Using formal consensus techniques according to recommendations of the Association of the scientific medical societies in Germany (AWMF), the guideline presented was developed in cooperation with the occupational groups involved in the rehabilitation process. Its structure focuses on the therapeutic targets, and it includes a clinical algorithm illustrating the orthopaedic rehabilitation process in a simple and understandable manner. The guideline presented is based on recent knowledge and corresponds to stage S2 of development. A further implementation project will evaluate practicability and acceptance of this guideline.
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T Haber, M Oehzelt, R Resel, A Andreev, A Thierry, H Sitter, D M Smilgies, B Schaffer, W Grogger (2006)  Single crystalline nature of para-sexiphenyl crystallites grown on KCl(100).   J Nanosci Nanotechnol 6: 3. 698-703 Mar  
Abstract: This work focuses on studies of the single crystal nature of para-sexiphenyl structures grown on freshly cleaved KCl(100) surfaces. Two different kinds of morphologies, namely terrace like structures and needle like structures, are found by atomic force microscopy as well as by electron microscopy. Regardless of the morphology the individual crystallites show highly regular shapes. The crystalline alignment and the degree of order of the crystallites on the surface are determined by X-ray diffraction. Several epitaxial alignments of para-sexiphenyl on KCl(100) are observed and all of them are perfectly aligned on the surface. The rocking curve widths of the organic crystallites do not exceed 800" which is approximately only the four fold of the substrates' ones. The single crystalline nature of para-sexiphenyl crystallites is proven by transmission electron microscopy, diffraction patterns, dark field imaging and high resolution techniques. Single crystalline terraced mounds reach diameters of several microns and heights of 50 nm. Single crystal needles show heights and breadths of more than 100 nm and lengths of several microns.
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2005
I Hassan, H Sitter, K Schlosser, A Zielke, M Rothmund, B Gerdes (2005)  A virtual reality simulator for objective assessment of surgeons' laparoscopic skill   Chirurg 76: 2. 151-156 Feb  
Abstract: BACKGROUND: The aim of this study was to validate computed virtual reality simulation as a tool to assess laparoscopic skills and to establish whether the simulator allows differentiating between surgeons with different laparoscopic experience. METHODS: 27 physicians at the surgical department of the University of Marburg, Germany, with different experience in laparoscopic surgery were divided into three groups: experienced (group I), intermediate (group II), and novices (group III). Following a brief introduction to the virtual reality simulator (LapSim), each participant performed twice a training program consisting of seven tasks (examinations I and II). RESULTS: Comparison of experienced surgeons with less experienced laparoscopic physicians showed a significant (P<0.05) superiority of group I at examinations I and II in most exercises. The groups' difference was more obvious in examination II, since the technique was new for all participants during examination I. Tasks of low complexity in virtual reality such as camera navigation, which are performed by young, not yet responsible surgeons in real surgery, did not show significantly different results between the three groups. CONCLUSION: Differences in laparoscopic experience can be visualised with a virtual reality simulator, and thus a simulator is helpful for assessing surgeons' laparoscopic skills.
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Nikolay R Sapundzhiev, Anja A Dünne, Annette Ramaswamy, Helmut Sitter, R Kim Davis, Jochen A Werner (2005)  Lymph node metastasis in an animal model: effect of piecemeal laser surgical resection.   Lasers Surg Med 36: 5. 371-376 Jun  
Abstract: BACKGROUND AND OBJECTIVES: Endoscopic laser surgical resection of advanced squamous cell carcinoma (SCC) often requires division of the tumor into several pieces. It is unknown if this approach influences the incidence of regional and distant metastases. STUDY DESIGN/MATERIALS AND METHODS: In 143 rabbits VX2 SCC was induced. Eight days later the tumor was resected by two different methods. In the first group en bloc cold steel resection was performed. In the second group piecemeal laser resection was performed. On the 51th day the animals were sacrificed and examined for lymph node and distant metastases. RESULTS: After piecemeal laser resection 47.7% of the animals had lymph node metastases compared to 24.6% after en bloc resection (P = 0.01). The incidence of distant metastases did not differ for the two groups. CONCLUSIONS: In our model narrow margin piecemeal laser resection was associated with a higher incidence of metastases compared to wide en bloc surgical resection. The exact mechanism responsible for this increase is unclear.
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2004
C Hasse, M Brune, W Lorenz, P Barth, W Metzler, G Breves, H Sitter (2004)  Functional parameters before and after parathyroidectomy: a prospective, randomized long-term trial on different rat strains.   Exp Clin Endocrinol Diabetes 112: 7. 364-372 Jul  
Abstract: For clinical controls before and after parathyroidectomy and for evaluation of the function of transplants of parathyroid tissue, it is necessary to establish standard values of relevant laboratory parameters for donor and recipient animals as well as for different types of nutrition. Since no such data are yet available, it was the purpose to define such standards. In a prospective randomized trial on 400 rats of the Dark Agouti (DA) and Lewis strain, different functional laboratory parameters such as total calcium, intact parathyroid hormone, phosphate, 1.25-dihydroxyvitamin D, and alkaline phosphatase were measured under a standard and low calcium diet over a period of 40 weeks. Two hundred of these animals underwent a parathyroidectomy four weeks after the beginning of the study and specimens were evaluated histologically. For all eight different study groups normal values could be defined within tight limits for parameters which describe the function of the parathyroid gland or elements of calcium metabolism under different conditions. The optimal conditions for a transplantation model of parathyroid glands were established. Lewis-rats were identified as the ideal donor and DA rats as the better recipient animals. These data can serve as reference values for future studies on transplantation of the parathyroid without immunosuppression.
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Volker Wenzel, Anette C Krismer, H Richard Arntz, Helmut Sitter, Karl H Stadlbauer, Karl H Lindner (2004)  A comparison of vasopressin and epinephrine for out-of-hospital cardiopulmonary resuscitation.   N Engl J Med 350: 2. 105-113 Jan  
Abstract: BACKGROUND: Vasopressin is an alternative to epinephrine for vasopressor therapy during cardiopulmonary resuscitation, but clinical experience with this treatment has been limited. METHODS: We randomly assigned adults who had had an out-of-hospital cardiac arrest to receive two injections of either 40 IU of vasopressin or 1 mg of epinephrine, followed by additional treatment with epinephrine if needed. The primary end point was survival to hospital admission, and the secondary end point was survival to hospital discharge. RESULTS: A total of 1219 patients underwent randomization; 33 were excluded because of missing study-drug codes. Among the remaining 1186 patients, 589 were assigned to receive vasopressin and 597 to receive epinephrine. The two treatment groups had similar clinical profiles. There were no significant differences in the rates of hospital admission between the vasopressin group and the epinephrine group either among patients with ventricular fibrillation (46.2 percent vs. 43.0 percent, P=0.48) or among those with pulseless electrical activity (33.7 percent vs. 30.5 percent, P=0.65). Among patients with asystole, however, vasopressin use was associated with significantly higher rates of hospital admission (29.0 percent, vs. 20.3 percent in the epinephrine group; P=0.02) and hospital discharge (4.7 percent vs. 1.5 percent, P=0.04). Among 732 patients in whom spontaneous circulation was not restored with the two injections of the study drug, additional treatment with epinephrine resulted in significant improvement in the rates of survival to hospital admission and hospital discharge in the vasopressin group, but not in the epinephrine group (hospital admission rate, 25.7 percent vs. 16.4 percent; P=0.002; hospital discharge rate, 6.2 percent vs. 1.7 percent; P=0.002). Cerebral performance was similar in the two groups. CONCLUSIONS: The effects of vasopressin were similar to those of epinephrine in the management of ventricular fibrillation and pulseless electrical activity, but vasopressin was superior to epinephrine in patients with asystole. Vasopressin followed by epinephrine may be more effective than epinephrine alone in the treatment of refractory cardiac arrest.
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H Sitter, S Hoffmann, I Hassan, A Zielke (2004)  Diagnostic score in appendicitis. Validation of a diagnostic score (Eskelinen score) in patients in whom acute appendicitis is suspected.   Langenbecks Arch Surg 389: 3. 213-218 Jun  
Abstract: BACKGROUND AND AIM: At times, the diagnosis of acute appendicitis may be difficult. However, for minimum morbidity to be obtained, early and accurate diagnosis is essential. This study aimed to validate a scoring system proposed by Eskelinen et al. as an aid in making the diagnosis of appendicitis. PATIENTS AND METHODS: The prospectively documented data of a consecutive series of 2,359 patients admitted for suspicion of appendicitis were used for validation. Accuracy and positive predictive value were defined as the main overall performance parameters, as was the rate of unnecessary operations to assess changes of patient management. Overall performance was assessed by receiver-operator characteristics (ROC) analysis. RESULTS: Of 2,359 patients, 662 were proven to have acute appendicitis (prevalence of 28%). The overall sensitivity, specificity, positive and negative predictive value, and accuracy of the score were 0.79, 0.85, 0.68, 0.91 and 0.835 at a cut-off value of 55. Calibration of the score's cut-off value to 57 yielded more favourable results (0.72, 0.91, 0.76, 0.9 and 0.86), and the rate of unnecessary operations declined from 26.6% to 15.4% ( P<0.05, chi2). ROC analysis revealed an area index of 0.91. CONCLUSION: The Eskelinen score delivered acceptable clinical results only after calibration to a cut-off value of 57. The data from this study suggest the investigation of whether a calibrated score might be particularly instrumental in the pre-admission evaluation of the patient in whom appendicitis is suspected.
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C Hasse, H Sitter, M Brune, I Wollenteit, W Lorenz, M Rothmund (2004)  Haemorrhoidectomy: conventional excision versus resection with the circular stapler. Prospective, randomized study   Dtsch Med Wochenschr 129: 30. 1611-1617 Jul  
Abstract: BACKGROUND AND OBJECTIVE: The goal of this study was to compare two surgical methods of treating for haemorrhoids that aim at closure of the wound: resection with a circular stapler and a conventional, closed haemorrhoidectomy. PATIENTS AND METHODS: 80 patients (41 males, mean age 47,1 years) with haemorrhoids stage 3 were randomized and treated with stapler haemorrhoidectomy (test group; n = 40) or had an haemorrhoidectomy according to Fansler and Anderson (control group; n = 40). Following a standardized study protocol we compared postoperative results on the operating day and one week, six weeks, six months and one year afterwards uni- and multivariate analysis and we also calculated the costs. RESULTS: The stapler haemorrhoidectomy proved to be the method causing significantly reduced pain in the early postoperative period so that the patients needed less pain relief. They were able to return to work earlier. One year after stapler haemorrhoidectomy there were three episodes of postoperative bleedings that required intervention, one in the control group. Six patients still had haemorrhoids stage 3, six patients over the age of 65 had persistent anal incontinence (I degrees according to Parks) with proven sphincter dysfunction and disturbances in voiding their bowel with resulting deterioration of quality of life, significantly more frequent than in the control group. CONCLUSIONS: Stapler haemorrhoidectomy cures stage 3 haemorrhoids on a long term basis in 84.2 % of patients, costing less than all alternative treatments. In some cases, it can be associated with postoperative complications.
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Martin Gotthardt, Bodo Lohmann, Thomas M Behr, Artur Bauhofer, Christiane Franzius, Meike L Schipper, Maria Wagner, Helmut Höffken, Helmut Sitter, Matthias Rothmund, Klaus Joseph, Christoph Nies (2004)  Clinical value of parathyroid scintigraphy with technetium-99m methoxyisobutylisonitrile: discrepancies in clinical data and a systematic metaanalysis of the literature.   World J Surg 28: 1. 100-107 Jan  
Abstract: There is a considerable discrepancy in the literature concerning the sensitivity of parathyroid scintigraphy (PS) with 99mTc-MIBI. We therefore analyzed our own data and compared them to the literature in a metaanalysis. All patients who received 99mTc -MIBI scintigraphy and subsequent surgery in our department for the detection of enlarged parathyroid glands in primary (pHPT) or secondary (sHPT) hyperparathyroidism between 1991 and 1999 were included in our retrospective analysis. The results of surgery served as the gold standard. For a true positive result, the scintigraphy had to predict the exact location of parathyroid adenoma (PA) or parathyroid hyperplasia (PH). We then compared these data to the results of a nonstatistical systematic metaanalysis of the literature. Patients (178) underwent PS between 1991 and 1999; 139 were operated on and included in this study. Of these, 109 had pHPT and 30 had sHPT. The sensitivity and specificity of the PS were found to be 45%/94% for pHPT and 39%/40% for sHPT. Fifty-two studies concerning PS were included in the metaanalysis. Sensitivities reported varied from 39% to >90%. Consideration of the different possible techniques used for PS could not explain these discrepancies. Our data show that the sensitivity of PS in clinical routine may be lower than expected from the literature. Our data are consistent with other studies and with partially unpublished clinical observations from other university hospitals. We believe that a well-designed and properly conducted prospective study is necessary to evaluate the reasons for the differences observed.
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C Hasse, M Brune, S Bachmann, W Lorenz, M Rothmund, H Sitter (2004)  Lateral, partial sphincter myotomy as therapy of chronic anal fissue. Long-term outcome of an epidemiological cohort study   Chirurg 75: 2. 160-167 Feb  
Abstract: AIM: We observed a relatively high rate of severe forms of anal incontinence in patients who had undergone lateral, partial, internal, open sphincterotomy for chronic fissure in ano years ago in our clinic. An explicit investigation of pre- and postoperative data for a representative patient group was undertaken to find out whether this incidental finding proved to be meaningful. PATIENTS AND METHODS: The perioperative data from 523 patients who underwent sphincterotomy (Parks) between 1986 and 1997 were analyzed by uni- and multivariate analysis. RESULTS: Of 209 patients included in the study, 94.7% could be considered healed after operation. Up until the 12th postoperative week, 14.8% of patients were incontinent in stage I and II (Parks). This increased up to 21% at the time of follow-up, mainly in stage II and III, which significantly differed from a healthy control group. CONCLUSION: Lateral sphincterotomy leads in most cases to quick healing of the chronic fissure in ano with a low recurrence rate. The added effect of degenerative changes was observed to be linked, however, with a higher long-term rate of anal incontinence.
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Katja Schlosser, Helmut Sitter, Matthias Rothmund, Andreas Zielke (2004)  Assessing the site of recurrence in patients with secondary hyperparathyroidism by a simplified Casanova autograftectomy test.   World J Surg 28: 6. 583-588 Jun  
Abstract: Patients with recurrent secondary hyperparathyroidism (rSHPT) following total parathyroidectomy and autotransplantation were prospectively studied by a modified Casanova test to discriminate between the graft-bearing arm and the neck as the site of the recurrence. The test measures intact parathyroid hormone (PTH) in blood obtained from the non-graft-bearing arm before an ischemic period and from the arm bearing the parathyroid graft during an ischemic period caused by an Esmarch bandage. The aim of this study was to evaluate the time course of PTH levels during the test and to establish an abbreviated procedure. A series of 30 patients with rSHPT who were admitted for reoperative surgery between 1994 and 2002 were studied. Systemic PTH levels were determined prior to suprasystolic exclusion of the graft-bearing arm as well as 2, 4, 6, 8, 10, 20, and 30 minutes during it and at 10 minutes afterward. Results were interpreted with a simple algorithm that suggested graft-dependent recurrence (GDR) whenever PTH levels dropped by more than 50% and neck-dominated recurrence (NDR) whenever the PTH levels dropped to less than 20%. Patients were operated on accordingly. Biochemical normalization of calcium and PTH was defined as success. Altogether, 15 patients had GDR and were cured after graft explantation. All of these patients were identified within 4 minutes of starting the test. Another 12 patients had NDR and were cured by excising overlooked or supernumerary glands. PTH levels were indeterminate in three patients (10%). Clinically, NDR is likely in all of these cases, but the test results were firmly established with 100% accuracy 8 minutes after the start of the test procedure. This abbreviated form of the Casanova test is advantageous for accurately determining the site of recurrence in the presence of rSHPT. It is less time-consuming, satisfactory in an ambulatory setting, equally effective, and less invasive than the original Casanova procedure.
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C Margolis, A Jotkowitz, H Sitter (2004)  A problem solving and decision making toolbox for approaching clinical problems and decisions.   Inflamm Res 53 Suppl 2: S179-S183 Aug  
Abstract: In this paper, we begin by presenting three real patients and then review all the practical conceptual tools that have been suggested for systematically analyzing clinical problems. Each of these conceptual tools (e.g. Evidence-Based Medicine, Clinical Practice Guidelines, Decision Analysis) deals mainly with a different type or aspect of clinical problems. We suggest that all of these conceptual tools can be thought of as belonging in the clinician's toolbox for solving clinical problems and making clinical decisions. A heuristic for guiding the clinician in using the tools is proposed. The heuristic is then used to analyze management of the three patients presented at the outset.
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H Sitter, A Torossian, D Duda, J Sattler (2004)  Classification of perioperative histamine-related reactions.   Inflamm Res 53 Suppl 2: S164-S168 Aug  
Abstract: OBJECTIVE: Histamine release may cause anaphylactoid reactions. However, during anaesthesia and surgery especially cardiovascular effects may not be regarded as histamine-related. Therefore, we adapted the classical concept of histamine release reactions to the perioperative situation and validated the new paradigm. METHODS: Elevated plasma histamine (diagnostic gold standard) was correlated to potentially related intraoperative signs and symptoms. The validity, repeatability and sensitivity of the 'gold standard' was tested by ROC analysis in volunteers, who also received H1-/H2-histamine antagonists. Additionally, a dose-response relationship was determined in dogs using the histamine releaser compound 48/80. RESULTS: The 'gold standard' had a sensitivity of 96% (90%-100%) and a specificity of 93% (85%-100%). The reproducibility was proven by repeated injections of histamine. Skin reactions, tachycardia and hypertension were identified as histamine-related diagnostic variables. A dose-response curve of plasma histamine release was created. CONCLUSIONS: The defined 'gold standard' is valid for the diagnosis of histamine-related reactions during anaesthesia and surgery. It may help to identify patients, who could benefit from pre-anaesthetic antihistamine prophylaxis.
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2003
Helmut Sitter, Wilfried Lorenz, Uwe Nicolay, Walter Krack, Armin Hellenbrandt, Andreas Zielke, Hartwig Gajek, Gertrud Ledertheil (2003)  From clinical evidence to everyday practice: implementing findings from a cost-effectiveness analysis for endoscopic injection therapy for upper-gastrointestinal bleeding.   Eur J Gastroenterol Hepatol 15: 3. 295-304 Mar  
Abstract: BACKGROUND: A previous upper-gastrointestinal bleeding trial showed that patients treated with repeated fibrin glue injection for upper-gastrointestinal bleeding have significantly less rebleeding than those treated with polidocanol. OBJECTIVE: To analyse the cost and effectiveness of repeated fibrin glue injection and to investigate whether these results change physicians' attitudes. DESIGN: A retrospective random sample of five hospitals from the previous study, collection of cost identification, and follow-up data on 320 patients (155 in the polidocanol group, 165 in the fibrin glue group). METHODS: An incremental cost-effectiveness analysis and comparison of outcomes was performed using chi-squared tests and Kaplan-Meier survival analysis. A survey was carried out using a questionnaire in the five hospitals on local guidelines for management of ulcer bleeding, and its results were analysed qualitatively. The measure of effectiveness is the number of prevented rebleedings. Further variables were length of hospital stay and length of intensive care unit (ICU) stay. RESULTS: The cost for the prevention of one additional rebleeding by repeated fibrin glue treatment amounts to 14,316 +/- 4981 euros (incremental cost-effectiveness ratio). There were no significant differences in length of stays in ICU or in hospital. The physicians did not change their management plans for patients with upper-gastrointestinal bleeding. In a survey, it was seen that other factors, such as local guidelines, attitudes towards new treatment options, and ease of handling of drugs, are more important than a result of a single study for a behavioural change of the doctors. CONCLUSIONS: The study was not designed prospectively to address a pharmacoeconomic question. As relevant variables (e.g. length of ICU stay) could not be reliably ascertained retrospectively, this may lead to biased estimates of the incremental cost-effectiveness ratio.
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E W Gerharz, J A Gasser, L Mosekilde, C Moniz, H Sitter, P J Barth, J S Thomsen, P G Ransley, H Riedmiller, C R J Woodhouse (2003)  Skeletal growth and long-term bone turnover after enterocystoplasty in a chronic rat model.   BJU Int 92: 3. 306-313 Aug  
Abstract: OBJECTIVE: To investigate skeletal growth and bone metabolism in a chronic animal model of urinary diversion. MATERIALS AND METHODS: Young male Wistar rats (120) were allocated randomly to four groups undergoing: ileocystoplasty, ileocystoplasty and resection of the ileocaecal segment, colocystoplasty, and controls. All animals received antibiotics for 1 week after surgery; half of each group remained on oral antibiotics. Bone-related biochemistry was measured in serum and urine. Dual-energy X-ray absorptiometry and peripheral quantitative computed tomography (pQCT) were used to determine bone mass ex vivo. RESULTS: Most (90%) of the rats survived the study period (8 months); six rats died from bowel obstruction at the level of the entero-anastomosis and four had to be killed because of persistent severe diarrhoea. Vital intestinal mucosa was found in all augmented bladders. There were no differences in bone length and volume. Loss of bone mass was almost exclusively in rats with ileocystoplasty and resection of the ileocaecal segment (-37.5%, pQCT, P < 0.01). There was no hyperchloraemic metabolic acidosis or gross impairment of renal function. Hypomagnesaemia, hypocalcaemia and decreased insulin-like growth factor-binding protein 3 were the only significant findings on blood analysis. Deoxypyridinoline crosslinks in urine were higher in rats with an enterocystoplasty than in controls. CONCLUSIONS: Enterocystoplasty in rats neither impairs skeletal growth nor bone quantity, but leads to significant loss of bone mass when combined with resection of the ileocaecal segment. Rarefaction of the trabecular network is confined to the metabolically highly active cancellous compartment, most likely as a consequence of intestinal malabsorption.
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C Hofmann, M Schädel-Höpfner, T Berns, H Sitter, L Gotzen (2003)  Influence of processing and sterilization on the mechanical properties of pins made from bovine cortical bone   Unfallchirurg 106: 6. 478-482 Jun  
Abstract: In a biomechanical study pins made of xenogenous cortical bone were tested in vitro. Forty pins of 3 mm diameter and 60 mm length were made of eight different cattle tibiae and allocated to five different treatment groups. Freeze-dried pins served as control group. Pins of the second group were preserved in concentrated sodium chloride solution and defatted with acetone (Tuto-plast processing). Pins of groups three to five were treated with sodium chloride and acetone and afterwards sterilized by different means (ethylene oxide, autoclavation, or gamma radiation). All pins were subjected to a three-point-bending test and a shear test. We found that bending strength and shearing strength were most increased after sodium chloride and acetone treatment, whereas after sterilization with ethylene oxide or autoclaving, the stability of the pins was similar to the control group. The stability was considerably diminished after gamma radiation. Taking into account possible toxic side effects of ethylene oxide, we conclude that Tutoplast processing followed by autoclavation presents a reliable preparation method for the clinical use of implants made of bovine cortical bone.
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2002
T Riegel, T Schilling, H Sitter, L Benes, A Wilke, M W Gross, H Bertalanffy (2002)  Analysis of factors affecting the prognosis of vertebral metastases   Zentralbl Neurochir 63: 1. 2-6  
Abstract: The goal of this study was to evaluate factors for the prognosis of patients with metastatic spinal tumors. 139 patients with vertebral metastases were studied. The modified Tokuhashi Score (a preoperative score composed of six parameters) and single factors were analysed with statistical methods. The modified Tokuhashi Score showed a significant correlation (p = 0,0019) with survival time of patients. Additionally, only the Karnofsky Index as single parameter showed statistically significant correlation(p = 0.0016). Regarding the logistic regression, primary tumor, age, sex and Karnofsky Index were identified as prognostic factors for survival time. This trial could demonstrate that the Tokuhashi Score is a successful predicting tool for the assessment of prognosis of patients with vertebral metastases.
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Christian Hasse, Helmut Sitter, Melanie Brune, Ina Wollenteit, Christoph Nies, Matthias Rothmund (2002)  Quality of life and patient satisfaction after reoperation for primary hyperparathyroidism: analysis of long-term results.   World J Surg 26: 8. 1029-1036 Aug  
Abstract: Morbidity after reoperation for persistent or recurrent primary hyperparathyroidism (pHPT) is higher than after primary surgery. According to our experience, there is a contrast between postoperative normalization of laboratory parameters and the quality of life/patient satisfaction after reoperation. Therefore the aim of the study was to analyze the outcomes of reoperations in comparison to primary surgery. We evaluated the patients' reported quality of life using the SF-36 (an accepted health status assessment tool) and complete prospectively documented perioperative and follow-up data including postoperative complications. Additionally, we searched for reasons why primary surgical intervention did not succeed. In a prospective cohort study the perioperative data of 653 consecutive patients with pHPT, including 75 reoperated patients (11.5%) who underwent parathyroidectomy between 1987 and 1999, were evaluated by uni- and multivariate analysis. At a median 78 months (6-156 months) postoperatively, all patients underwent a planned follow-up that included the SF-36, physical examination, and laboratory investigations. A total of 51 reoperated patients were available for follow-up. Postoperative alleviation of symptoms or being symptom-free was reported by 70.6%. Patients after reoperation had lower SF-36 scores in all health domains postoperatively than patients after a primary operation. Of the reoperated patients, 19.6% stated that after evaluating the development of their complaints they would not consent to reoperation again. Subgroup analysis showed that 80% of patients with postoperatively persistent pHPT, 60% of those who did not observe symptom alleviation, and 44% of those after sternotomy were in the group of dissatisfied patients. Surprisingly, none of the patients with more than one reoperation, only two of the five patients with permanent recurrent laryngeal nerve injury, and only one of the four patients with persistent hypoparathyroidism were dissatisfied overall. Parathyroidectomy resulted in normocalcemia in 90.2% of the reoperated patients, with an operative morbidity of 27.4% and no mortality. After an unsuccessful operation for pHPT, patients should be treated at an expert center to avoid persistent hypercalcemia. Reoperations necessitating sternotomy should be restricted to patients with severe symptoms and signs.
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H de Sitter, P W J Peters (2002)  Biotechnology, especially genetic modification, and legislation   Tijdschr Diergeneeskd 127: 10. 322-330 May  
Abstract: Biotechnology and genetic modification (GM) related legislation is not yet fully developed in the European Union (EU). New legislation has been recently issued ('Introduction of GMO's in the environment') and recently proposals from the European Commission ('GMO's in food and feed' and 'Traceability and labelling of GMO's') entered the decision-making process in the end of 2001. The proposals for the establishment of the European Food Authority play a role in this respect. GMO legislation is complex not in the least because of the demands for the dossiers, to be submitted with an application, while these procedures for admission must become more transparent. In this paper the relevant legislation will be discussed with the exception of that related to human health. Because of dissatisfaction with the present legislation, the European Commission in the past years granted no new approvals for introductions on the market of GMO's and for GM novel foods. New legislation should suspend the present de-facto moratorium. The tasks and position of the Inspectorate for the Health Protection and Veterinary Public Health is discussed. A provision has been made in the legislation with respect to adventitious or technically unavoidable contamination of raw materials with GMO's up to a maximum of 1%, of which the enforcement is not yet watertight. The analytical methods are being still developed.
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2001
W Lorenz, B Stinner, A Bauhofer, M Rothmund, I Celik, A Fingerhut, M Koller, R H Lorijn, P O Nyström, H Sitter, M Schein, J S Solomkin, H Troidl, J Wyatt, D H Wittmann (2001)  Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol of a controlled clinical trial developed by consensus of an international study group. Part one: rationale and hypothesis.   Inflamm Res 50: 3. 115-122 Mar  
Abstract: GENERAL DESIGN: Presentation of a novel study protocol to evalue the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). The rationale and hypothesis are presented in this part of the protocol of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). OBJECTIVE: Part one of this protocol describes the concepts of three major sections of the study: Definition of optimum and sub-optimal recovery after operation. Recovery, as an outcome, is not a simple univariate endpoint, but a complex construction of mechanistic variables (i. e. death, complications and health status assessed by the surgeon), quality of life expressed by the patient, and finally a weighted outcome judgement by both the patient and the surgeon (true endpoint). Its conventional early assessment within 14-28 days is artificial: longer periods (such as 6 months) are needed for the patient to state: "I am now as well as I was before". Identification of suitable target patients: the use of biological response modifiers (immune modulators) in addition to traditional prophylaxes (i. e. antibiotics, heparin, volume substitutes) may improve postoperative outcome in appropriate selected patients with reduced host defence and increased immunological stress response, but these have to be defined. Patients classified as ASA 3 and 4 (American Society for Anaesthesiologists) and with colorectal cancer will be studied to prove this hypothesis. Choice of biological response modifier: Filgrastim has been chosen as an example of a biological response modifier because it was effective in a new study type, clinic-modelling randomised trials in rodents, and has shown promise in some clinical trials for indications other than preoperative prophylaxis. It has also enhanced host defence and has been anti-inflammatory in basic research. CONCLUSION: The following hypothesis will be tested in patients with operations for colorectal cancer and increased preoperative risk (ASA 3 and 4): is the outcome as evaluated by the hermeneutic endpoint (quality of life expressed by the patient) and mechanistic endpoints (mortality rate, complication rate, relative hospital stay, assessed by the doctor) improved in the group receiving filgrastim prophylaxis in comparison with the placebo group? Quality of life will be the first primary endpoint in the hierarchical, statistical testing of confirmatory analysis.
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J T Heverhagen, N Ishaque, A Zielke, T Bohrer, H Sitter, L D Berthold, K J Klose (2001)  Feasibility of MRI in the diagnosis of acute diverticulitis: initial results.   MAGMA 12: 1. 4-9 Mar  
Abstract: PURPOSE: The purpose of this study was to evaluate MRI as a diagnostic tool in patients with suspected acute sigmoid diverticulitis. Furthermore, we sought to develop an optimal imaging protocol in these patients. PATIENTS AND METHODS: Eleven patients with suspected acute diverticulitis were included in the study. All patients were imaged in a 1.0 T clinical scanner using a body-array coil. Imaging sequences were single-shot TSE, HASTE-, STIR- and TrueFisp- sequence. All were obtained in the frontal plane. The diagnosis was verified by a single experienced investigator, using ultrasound, and overall clinicopathological outcome. RESULTS: MRI enabled visualization of signs of an acute diverticulitis in all patients. However, the diagnosis of acute diverticulitis was obtained in 10 patients only. The mean imaging time was 17.5+/-5.5 min. STIR- and TrueFisp-sequences alone displayed all findings, e.g pericolonic exsudation, edema and segmental narrowing, whereas SSTSE and HASTE-sequences showed no additional information. Therefore, it appeared that the imaging protocol could be restricted to STIR- and TrueFisp-sequences. CONCLUSION: MRI is feasible as a fast, accurate and investigator-independent diagnostic tool in patients with suspected acute diverticulitis. To prove its value in comparison to computed tomography or ultrasound, further studies are needed.
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A Zielke, H Sitter, T Rampp, T Bohrer, M Rothmund (2001)  Clinical decision-making, ultrasonography, and scores for evaluation of suspected acute appendicitis.   World J Surg 25: 5. 578-584 May  
Abstract: Diagnosing acute appendicitis (aA) remains difficult. This study evaluated the utility of ultrasonography (US) compared to clinical decision-making alone and scoring systems to establish the indication for laparotomy in patients in whom aA was suspected. The prospectively documented data of 2209 patients admitted for suspicion of aA, who underwent US by one of 12 surgeons, formed a database in which the diagnostic and procedural performance of clinical decision-making, US, two scoring systems (Ohmann and Eskelinen scores), and clinical algorithms taking account of clinical and either US findings or score results, were retrospectively evaluated. The results of either modality were correlated with final diagnoses obtained by laparotomy in 696 patients, of whom 540 had aA (prevalence 24.45%) and follow-up data in the remainder. US had the highest specificity (97%, compared to 93% for the Ohmann and Eskelinen scores and 94% for the clinical evaluation and algorithms) and lowest overall rate of false-positive findings (negative laparotomy rate 7.6%). The scores were accurate in refuting the diagnosis of aA but otherwise not superior to US. The best overall diagnostic and procedural results were obtained with the algorithms that combined the results of either US or the Ohmann score with clinical evaluation, which produced the most favorable numbers of negative laparotomies, potential perforations, and missed cases of aA. US is the diagnostic standard of reference for patients with a possible diagnosis of aA. It yields diagnostic results superior to those of scoring systems and provisional clinical evaluation. However, the benefits of US by ultrasonographically trained surgeons are only fully appreciated within the context of clinical algorithms. The joint evaluation of score results and clinical evaluation may deliver information of similar accuracy.
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C Nies, I Celik, W Lorenz, M Koller, U Plaul, W Krack, H Sitter, M Rothmund (2001)  Outcome of minimally invasive surgery. Qualitative analysis and evaluation of the clinical relevance of study variables by the patient and physician   Chirurg 72: 1. 19-28; discussion 28-9 Jan  
Abstract: INTRODUCTION: Mechanistic study endpoints, evaluated exclusively by the physician, are mostly used in clinical studies evaluating new treatment modalities (e.g. laparoscopic cholecystectomy). Those endpoints often lack clinical relevance. The patient's opinion concerning the importance of a study endpoint is particularly important in the evaluation of minimally invasive procedures, which place special emphasis on patient comfort. METHODS: In a first step it was evaluated by meta-analysis, which clinical endpoints have been used for comparison of laparoscopic and conventional cholecystectomy. Furthermore, using a qualitative analysis it was investigated how important the individual study endpoints are for patients and physicians. Ten patients and five surgeons were questioned in a structured interview. RESULTS: Of all outcome variables used world-wide, approximately one third were hermeneutic study endpoints, depending on the quality of the study, but often the method of evaluation was insufficient. Only three of 215 endpoints (< 2%) were quality of life scores, an integrated concept of outcome was missing completely. The qualitative analysis confirms the claimed difference between isolated and integrated evaluation of treatment goals. The importance of postoperative death is underestimated by patients and physicians; postoperative pain is overestimated. Patients ranked the outcome variable "restoration of full physical fitness" as the most important study endpoint after avoidance of complications and death. It is underestimated in isolated evaluation and has not been used in the world literature at all. CONCLUSION: The analysis of clinical relevance of study endpoints should be the first and not the last step of studies to evaluate surgical technology. It cannot be based purely on intuition; it must make use of scientifically accepted techniques (e.g. qualitative analysis).
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A Bauhofer, W Lorenz, B Stinner, M Rothmund, M Koller, H Sitter, I Celik, J R Farndon, A Fingerhut, J M Hay, R Lefering, R Lorijn, P O Nyström, H Schäfer, M Schein, J Solomkin, H Troidl, H D Volk, D H Wittmann, J Wyatt (2001)  Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol for a controlled clinical trial developed by consensus of an international study group. Part two: design of the study.   Inflamm Res 50: 4. 187-205 Apr  
Abstract: GENERAL DESIGN: Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). This part describes the design of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). OBJECTIVE: The trial design includes the following elements for a prototype protocol: * The study population is restricted to patients with colorectal cancer, including a left sided resection and an increased perioperative risk (ASA 3 and 4). * Patients are allocated by random to the control or treatment group. * The double blinding strategy of the trial is assessed by psychometric indices. * An endpoint construct with quality of life (EORTC QLQ-C30) and a recovery index (modified Mc Peek index) are used as primary endpoints. Qualitative analysis of clinical relevance of the endpoints is performed by both patients and doctors. * Statistical analysis uses an area under the curve (AUC) model for improvement of quality of life on leaving hospital and two and six months after operation. A confirmatory statistical model with quality of life as the first primary endpoint in the hierarchic test procedure is used. Expectations of patients and surgeons and the negative affect are analysed by social psychological scales. CONCLUSION: This study design differs from other trials on preoperative prophylaxis and postoperative recovery, and has been developed to try a new concept and avoid previous failures.
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B Stinner, A Bauhofer, W Lorenz, M Rothmund, U Plaul, A Torossian, I Celik, H Sitter, M Koller, A Black, D Duda, A Encke, B Greger, H van Goor, E Hanisch, R Hesterberg, K J Klose, F Lacaine, R H Lorijn, C Margolis, E Neugebauer, P O Nyström, P H Reemst, M Schein, J Solovera (2001)  Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol of a controlled clinical trial developed by consensus of an international study group. Part three: individual patient, complication algorithm and quality manage.   Inflamm Res 50: 5. 233-248 May  
Abstract: GENERAL DESIGN: Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). A randomised, placebo controlled, double-blinded, single-centre study is performed at an University Hospital (n = 40 patients for each group). This part presents the course of the individual patient and a complication algorithm for the management of anastomotic leakage and quality management. OBJECTIVE: In part three of the protocol, the three major sections include: The course of the individual patient using a comprehensive graphic display, including the perioperative period, hospital stay and post discharge outcome. A center based clinical practice guideline for the management of the most important postoperative complication--anastomotic leakage--including evidence based support for each step of the algorithm. Data management, ethics and organisational structure. CONCLUSIONS: Future studies with immune modifiers will also fail if not better structured (reduction of variance) to achieve uniform patient management in a complex clinical scenario. This new type of a single-centre trial aims to reduce the gap between animal experiments and clinical trials or--if it fails--at least demonstrates new ways for explaining the failures.
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2000
K Giannadakis, H Gehling, H Sitter, S Achenbach, H Hahne, L Gotzen (2000)  Is a general pharmacologic thromboembolism prophylaxis necessary in ambulatory treatment by plaster cast immobilization in lower limb injuries?   Unfallchirurg 103: 6. 475-478 Jun  
Abstract: Selected patients with minor lower limb injuries and low risk for deep vein thrombosis (DVT), who required cast immobilizing and did not receive medical thrombosis prophylaxis, were included in a prospective study. The decision to give not medical thrombosis prophylaxis depended on an concept of individualised prophylaxis for patients at risk for thromboembolism. From March 1994 to March 1996 in 178 outpatients (118 men, 60 women, mean age 25.8 [16-39] years) a clinical examination and a colour-coded duplex sonography were performed after removal of the cast for detection of DVT of the lower limb. A phlebography was performed when thrombosis was suspected. Two patients developed a one bundle thrombosis of the calf. Clinical appearance of lung embolism was not observed. These results suggest, that low risk patients with minor injuries of the lower limb and plaster cast immobilisation do not need a medical thrombosis prophylaxis.
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C Hasse, H Sitter, S Bachmann, A Zielke, M Koller, C Nies, W Lorenz, M Rothmund (2000)  How asymptomatic is asymptomatic primary hyperparathyroidism?   Exp Clin Endocrinol Diabetes 108: 4. 265-274  
Abstract: We observed several cases of patients who believed they were free of symptoms or signs of primary hyperparathyroidism (pHPT) preoperatively. reported a change of complaints following parathyroidectomy (PTX). We, therefore, decided to examine a larger group of patients to discover if these findings were incidental or of more general significance. The role of PTX in these patients with asymptomatic pHPT remains controversial. In 1991 criteria were defined at a NIH-consensus conference, according to which patients qualify for either operative therapy or long term medical surveillance. Until now, it was generally believed that the majority of asymptomatic patients would never develop symptoms. In a epidemiological cohort-study, the perioperative data of 582 consecutive patients with pHPT, including 116 asymptomatic patients (20.9%), who underwent parathyroidectomy between 1987 and 1998 were evaluated by uni- and multivariate analysis. At a median of 72 months postoperatively, all patients underwent a planned follow-up which included a standardised, validated questionnaire, physical examination and laboratory investigations. Eighty-six patients who were asymptomatic preoperatively were available for follow-up. Only eight (9.3%) were definitely asymptomatic, 4.6% of the entire, representative cohort. Postoperative improvement was reported in 81.4% of the "asymptomatic" patients. Multivariate analysis did not reveal a single or a set of preoperative measurements, that would allow to predict the retrospectively definitely asymptomatic patient. PTX resulted in normocalcaemia in 98.8% of preoperatively asymptomatic patients, with an operative morbidity of 1.2% and no mortality. Many apparently asymptomatic patients with pHPT will only realise that they did in fact have preoperative symptoms in retrospect, following PTX. This study suggests that using an up-to-date definition of asymptomatic pHPT, there are only a small number of truly asymptomatic patients and that these cannot be predicted preoperatively, as their symptoms may become apparent only after PTX. "Asymptomatic" patients with pHPT may share the same objective and subjective benefits from PTX as symptomatic patients. They should be operated as soon as the diagnosis is established.
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1999
A Zielke, H Sitter, T Rampp, E Schäfer, E Möbius, W Lorenz, M Rothmund (1999)  Can diagnostic scoring systems help decision making in primary care of patients with suspected acute appendicitis?   Dtsch Med Wochenschr 124: 18. 545-550 May  
Abstract: BACKGROUND AND OBJECTIVE: To assess two recently developed scoring systems with respect to making or excluding the diagnosis of acute appendicitis. PATIENTS AND METHODS: Data on 2359 patients with typical signs of acute appendicitis (AA) were analysed, the results of two diagnostic scoring systems being compared with the diagnosis made by an experienced surgeon. RESULTS: AA was confirmed in 662 of the 22,359 patients (prevalence 28%). Sensitivity, specificity, positive and negative predictive values and overall accuracy for diagnosis with the Ohmann scoring system were 0.63, 0.93, 0.77, 0.86 and 0.84; with the Eskelinen score the values were 0.79, 0.85, 0.68, 0.81 and 0.835; and by the surgeon they were 0.90, 0.94, 0.85, 0.96 und 0.93. The negative appendectomy or laparotomy rate was 14.3 an 12.3 respectively with the Ohmann score, 29.5 and 26.6 with the Eskelinen score. The numbers of potential and of nondiagnosed perforations were 41% and 37% respectively with the Ohman score and 26.6% and 16.3% with the Eskelinen score. The number of missed cases of AA was lowest with the Ohman scoring system, compared with 1.8% for the surgeon. After excluding AA, both scoring systems had a specificity of -0.99, with a positive probability rate of at least 27 (Eskelinen score) up to 87 (Ohman score). CONCLUSION: Both diagnostic scoring systems are better for excluding than correctly diagnosing AA; the decision to exclude could be made with a high degree of accuracy. Either scoring system may therefore be used in primary care of patients suspected of AA to help decide on referral to hospital.
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H Sitter, W Dietz, B Stinner, J Geks, A Bauhofer, I Celik, H Prünte, W Lorenz (1999)  Clinical guidelines as part of total quality management. Analysis of heterogenous treatment concepts of sepsis in various clinics with computer assisted generation, logical testing and complexity assessment of clinical algorithms   Zentralbl Chir 124: 4. 318-326  
Abstract: Generation, local tailoring, implementation and evaluation of clinical guidelines is an integral part of quality management. Clinical guidelines are intimately related to the independency of physicians' decisions. By this the physicians should be responsible for guideline development and guarantee the use of adequate methods of total quality management and outcome assessment. Formal consensus finding and transparency of evidence are necessary to guarantee the use of guidelines. Clinical algorithms are highly formalized and they are well suited for generation and analysis by the software ALGO. Determination of complexity and comparison of the clinical contents of algorithms is done by the scores CASA (Clinical Algorithm Structural Analysis) and CAPA (Clinical Algorithm Patient Abstraction). In a study of 22 clinical departments on treatment management concepts in sepsis following anastomotic insufFiciency in colorectal carcinoma a considerable heterogeneity was shown using this program.
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W Lorenz, H Troidl, J S Solomkin, C Nies, H Sitter, M Koller, W Krack, M F Roizen (1999)  Second step: testing-outcome measurements.   World J Surg 23: 8. 768-780 Aug  
Abstract: Despite worldwide enthusiasm for endoscopic surgery, this new technology is now on the top of McKinlay's "product life circle curve." Critical questions are being asked about its benefits and burdens, but the concepts applied and the methodologies used for technology assessment are in a similar position as endoscopic surgery and need a critical evaluation. (1) There are incorrect and outdated concepts for the scientific basis of surgery (surgical theory) including the basic sciences involved; biomedicine still dominates, but assessment of outcome after operations is no longer possible without clinical epidemiology and social psychology. (2) Based on an outdated scientific theory for surgery, an outdated concept of disease is still propagated. It is denoted as mechanical and is based solely on biomedicine. Human subjects are reduced to biologic machines, and outcomes measurement excludes most dimensions of functioning and well-being. To achieve a valid result for outcome measures, a hermeneutic approach must be combined with the mechanical approach. (3) Based on an outdated model of disease, the outcomes used in endoscopic surgery rely too much on traditional measures, such as mortality rate, complication rate, hospital stay, and especially an endless list of biochemical mediators. Their alterations during the perioperative period have not yet been shown to be related to clinical or hermeneutic outcomes. A new method of assessment for clinical trials in endoscopic surgery and for other surgical problems is outlined, such as for surgical infections and for surgical oncology. It includes an index of recovery and objective health status assessed by the doctor, a quality-of-life self-report by the patient, and the true endpoint concept as a critical weighting of both types of outcome by patients and doctors.
Notes:
A Zielke, H Sitter, T A Rampp, E Schäfer, C Hasse, W Lorenz, M Rothmund (1999)  Validation of a diagnostic scoring system (Ohmann score) in acute appendicitis   Chirurg 70: 7. 777-83; discussion 784 Jul  
Abstract: A diagnostic scoring system, recently published by Ohmann et al. in this journal, was validated by analyzing the clinicopathological data of a consecutive series of 2,359 patients, admitted for suspicion of acute appendicitis. The results of the scoring system were compared to the results of clinical evaluation by junior (provisional) and senior surgeons (final clinical diagnosis). To assess the diagnostic ability of the score, the accuracy and positive predictive value were defined as the major diagnostic performance parameters; the rate of theoretical negative laparotomies and that of diagnostic errors served as the major procedural performance parameters. Of 2,359 patients admitted for suspected acute appendicitis, 662 were proven to have acute appendicitis by histology, for a prevalence of 28%. The overall sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the provisional clinical diagnosis were 0.50, 0.94, 0.77, 0.83, and 0.82; 0.93, for the score 0.63, 0.93, 0.77, 0.86 and 0.84, and for the final clinical diagnosis 0.90, 0.94, 0.85, 0.96, and 0.93, respectively. Of the main diagnostic performance parameter, the accuracy of the score was significantly better than that of provisional clinical diagnosis (P < 0.05, chi 2 test). The score yielded a rate of negative appendecomies and laparotomies of 14.3 and 12.3%. With respect to the rate of overlooked cases of acute apendicitis, the score demonstrated a superior performance, with only 6 cases missed (0.9%). However, the number of patients with acute appendicitis, including those with perforated disease, who were not identified by the score, was almost four times that of the final clinical diagnosis (245 vs 63). With regard to the main procedural performance parameter, the score resulted in a significantly smaller number of diagnostic errors than the provisional clinical investigator (P < 0.05, chi 2 test). The results of this study indicate that the diagnostic scoring system might be helpful when experienced investigators or additional diagnostic modalities such as ultrasonography are not available. It may therefore be of value in the preclinical evaluation of patients with suspected acute appendicitis and may be instrumental as a quality control tool and in clinical guidelines.
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D K Mauer, J Nolan, P Plaisance, H Sitter, H Benoit, I G Stiell, E Sofianos, N Keiding, K G Lurie (1999)  Effect of active compression-decompression resuscitation (ACD-CPR) on survival: a combined analysis using individual patient data.   Resuscitation 41: 3. 249-256 Aug  
Abstract: Active compression decompression resuscitation (ACD-CPR) has been developed as an alternative to standard cardiopulmonary resuscitation (S-CPR). To determine the effect of ACD-CPR on survival and neurologic outcome in patients with out-of-hospital cardiac arrest, this combined analysis involved individual patient data from 2866 patients from seven separate randomized prospective prehospital studies who had received ACD-CPR or S-CPR after out-of-hospital cardiac arrest in seven international sites. Significant improvement in 1-h survival (odds ratio (OR) = 0.83; confidence interval (CI): 0.695-0.99; P < 0.05) was found with ACD-CPR (n = 1410) versus S-CPR (n = 1456). The odds ratio for hospital discharge after ACD-CPR was similar (OR = 0.82; CI: 0.609-1.107, P = NS), but this finding was not statistically significant. Using the chi2-test for trend, there was a significant improvement in overall survival with ACD-CPR (P < 0.05) versus S-CPR. This improvement was largely due to the influence of results from one study site. Neurological outcome and complication rates were comparable between groups. Further study is needed to determine which emergency medical services systems may benefit from out-of-hospital use of ACD-CPR.
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B Aust, T Ganslandt, H Sitter, U Prokosch, A Zielke, C Ohmann (1999)  Formal decision aids in surgery--results of a survey   Chirurg 70: 7. 823-829 Jul  
Abstract: Even though many decision-aids have been developed in the past, the application of these systems in clinical practice is still rare. There are many reasons for this, including the reservations of potential users. A survey in three university surgery clinics was conducted to assess the experience and attitudes towards decision-aids among physicians. Seventy-two of the 102 physicians approached (71%) filled out and returned the short questionnaire that was sent to them. More than half of the 72 survey participants already use decision-aids. Among them, guidelines are used most often (46%), whereas other instruments (algorithms, scores, decision trees) are used less frequently (10-17%). Computer-based decision-aids are hardly used at all (7%). These results are in contrast to the strong request for more decision-aids, especially for computer-based systems (40%). Physicians who already use decision-aids are more interested in additional systems. More than 70% of all participants are interested in more information about the topic. The standardized question about attitudes towards computer-based decision-aids reveals more positive than negative appraisal, whereas the answers to open questions focus more on objections. The substantial differences between the three survey locations in parts of the survey results show that attitudes towards decision-aids are influenced by the way the instruments are introduced and the way the users are informed and involved in the process of implementation. A successful implementation of decision-aids in clinical practice should therefore try to integrate the future users as much as possible.
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1998
A Zielke, C Hasse, H Sitter, M Rothmund (1998)  Influence of ultrasound on clinical decision making in acute appendicitis: a prospective study.   Eur J Surg 164: 3. 201-209 Mar  
Abstract: OBJECTIVE: To assess the efficacy of ultrasound (US) as part of an algorithm to establish the indication for laparotomy in patients with suspected acute appendicitis. DESIGN: Prospective investigation. SETTING: University department of surgery, Germany. SUBJECTS: 669 unselected patients admitted with suspected acute appendicitis. INTERVENTIONS: Clinicopathological and procedural diagnoses of the algorithm were evaluated by correlating clinical and US findings with the results of laparotomy in 171 patients of whom 143 had acute appendicitis (prevalence 21%), and clinical as well as follow up data in the remainder. MAIN OUTCOME MEASURES: The major clinicopathological variables were accuracy and positive predictive value; the rate of negative laparotomies and that of bad diagnostic errors served as the main procedural variables. RESULTS: The overall sensitivity, specificity, and accuracy of the clinical diagnosis were 0.503, 0.950, and 0.855, respectively (positive predictive value: PPV 0.734, negative predictive value: NPV 0.875), those of ultrasound: 0.797, 0.967, and 0.931 (PPV 0.870, NPV 0.946); and 0.853, 0.927, and 0.940 at the end of the algorithm (PPV 0.762, NPV 0.958). However, the algorithm would have resulted in a significant increase in the rate of unnecessary laparotomies (from 13% to 16%). A revised clinical algorithm gave an overall diagnostic accuracy of 0.940 (p < 0.001) together with a low rate of negative laparotomies (11%, p < 0.01) and a significantly reduced number of diagnostic errors (from 71 to 21, p < 0.001). CONCLUSION: Ultrasonography enabled us to diagnose acute appendicitis in more patients more often and more quickly than clinical evaluation alone, suggesting that US may produce a better outcome. The revised clinical algorithm may be helpful in the study of US in patients with suspected acute appendicitis in prospective randomised controlled clinical trials.
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C Hasse, A Zielke, G Klöck, A Schlosser, P Barth, U Zimmermann, H Sitter, W Lorenz, M Rothmund (1998)  Amitogenic alginates: key to first clinical application of microencapsulation technology.   World J Surg 22: 7. 659-665 Jul  
Abstract: Microencapsulation refers to a technique of immunoisolation by coating single cells or tissue with a semipermeable membrane. By combining microencapsulation with a specific tissue culturing method, iso-, allo-, and xenotransplantation of parathyroid tissue has been achieved without immunosuppression in a long-term animal model. Prior to its clinical use, continued analyses of the alginate, used as a coating substance, determined its mitogenic properties. Purification of the commercially available alginate was achieved using patented electrophoretic procedures, resulting in an amitogenic alginate suitable for use in humans. However, this alginate exhibited entirely different physical properties. We have recently shown that isotransplanted parathyroid tissue remains vital and functioning in vivo over long periods of time using the novel amitogenic alginate. It is essential to document, whether the alginate is able to maintain immunoisolation. We have therefore assessed its in vivo function compared to the mitogenic alginate in a transgenic animal model. Altogether 600 parathyroid glands from 300 Lewis rats (donor animals) were excised and subjected to tissue culture. Thereafter they were allotransplanted to 30 parathyroidectomized Dark-Auita rats, microencapsulated with the amitogenic or the mitogenic alginate or naked, with 10 recipient animals in each group. Total serum calcium and parathyroid hormone levels were monitored continuously at weekly intervals for 30 weeks. After 26 weeks the transplant beds were excised and subjected to histologic examination. More than 6 months after allotransplantation 9 of 10 animals that had received amitogenic transplants, compared to 7 of 10 animals in the group with mitogenic microcapsules were normocalcemic. Animals that had received naked parathyroid tissue were hypocalcemic as soon as 2 weeks after allotransplantation. Correspondingly, normocalcemic animals showed vital parathyroid tissue inside the microcapsules, which were surrounded by a significantly smaller rim of fibroblasts when amitogenic alginate had been used. In addition to confirming physiologic long-term function, we were able to document for the first time that immunoisolation can also be achieved with the novel amitogenic alginate, which is suitable for clinical use.
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I Celik, B Stinner, W Lorenz, W Dietz, S Sauer, D Duda, H Sitter, A Junge (1998)  Reduction of cardiovascular disorders by preventive perioperative antihistamine administration in general surgery: are the drugs interchangeable?   Langenbecks Arch Chir Suppl Kongressbd 115: Suppl I. 731-735  
Abstract: In clinical reality the drugs used for H1/H2-prophylaxis are not restricted to the combination of dimetinden/cimetidine, also only for this combination the effectiveness for preventing severe cardiorespiratory disturbances is proven in a randomised controlled clinical trial. However, it is almost impossible to conduct such an extended clinical trial in order to check all possible combinations. Instead of this, we developed a complex animal model featuring clinical variability and the principles of a well conducted randomised controlled clinical trial (CMRT = clinic modelling randomised trials), to evaluate different H1/H2 combinations. In this CMRT in pigs (four groups of 15 animals), the H1/H2 combination of dimetinden/cimetidine and dimetinden/famotidine showed an effectiveness similar to the randomised clinical trial. With dimetinden/ranitidine no significant prophylactic effect was observed. Two conclusions can be drawn: (1) CMRTs in animals are able to answer relevant clinical and research questions that otherwise only could be solved by clinical studies and may be a successful intermediate between basic research and clinical trials. (2) Drugs, even of the same substance class, may not be simply exchangeable. Hence, before changing a proven medication, trials in an adequate complex animal model (CMRT) should be mandatory.
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C Nies, W Krack, W Lorenz, H Sitter, T Kaufmann, I Celik, M Rothmund (1998)  Prediction of rehabilitation outcome after surgical interventions based on biochemical parameters: a new concept in mediator research   Langenbecks Arch Chir Suppl Kongressbd 115: Suppl I. 505-509  
Abstract: The perioperative changes in epinephrin-, norepinephrine-, histamin-, C5a- and interleukin-6-levels were studied in 40 patients undergoing cholecystectomy for the diagnosis of acute cholecystitis. All relevant mediator levels could be determined in 38 patients. The outcome was not optimal in 16 of them (42%). In order to evaluate the predictive value of the mediators under investigation for the quality of the patients' outcome, a model based on the Bayes' theorem was developed. Using this model the outcome (optimal vs. not optimal) could be correctly predicted in 30 (79%) of our study patients. This kind of data analysis allows to define states of increased risk for a not optimal recovery based on biochemical parameters.
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1997
A Encke, E Hanisch, H Sitter, B Greger, A Bauhofer, C Margolis, W Lorenz (1997)  Evaluation models for therapy planning/standardization exemplified by infection   Langenbecks Arch Chir Suppl Kongressbd 114: 323-329  
Abstract: Models of evaluation in therapeutic management pathways (practice guidelines, clinical algorithms) are demanded today, both by public health research and health policy. However, practical achievements are lacking. To overcome this controversy, the Lucerne Study Group on Sepsis Research was founded to develop guidelines in accordance with a series of official groups. It was shown that there was no agreement between the providers and the daily users. However, every surgeon has a firm, personal view about sepsis.
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A Zielke, C Hasse, C Nies, O Kisker, M Voss, H Sitter, M Rothmund (1997)  Prospective evaluation of ultrasonography in acute colonic diverticulitis.   Br J Surg 84: 3. 385-388 Mar  
Abstract: BACKGROUND: The clinical diagnosis of acute colonic diverticulitis (ACD) can be difficult and ultrasonography by experts is valuable in establishing the diagnosis. This prospective observational trial aimed to assess the diagnostic accuracy and clinical value of ultrasonography performed routinely by surgical residents in training. METHODS: The clinical course of 187 unselected consecutive patients admitted with suspected ACD was studied prospectively. Patients who had surgery for generalized peritonitis were excluded, leaving 143 for evaluation. Ultrasonographic findings and clinical assessment on admission were correlated with the patient's clinicopathological data and discharge diagnosis respectively. RESULTS: Of 74 patients with proven ACD (prevalence 52 per cent) the diagnosis was made by ultrasonography in 62, with an accuracy of 88 per cent, sensitivity 84 per cent and specificity 93 per cent. Ultrasonography gave a false-negative result in 12 patients (negative predictive value (NPV) 84 per cent) and there were five false-positive findings (positive predictive value (PPV) 93 per cent). The final diagnosis in the latter five patients was colitis (two patients), caecal carcinoma (one), colonic ileus due to perforated sigmoid carcinoma (one) and suppurative pyosalpingitis with involvement of the sigmoid colon (one). The accuracy of clinical evaluation on admission was 71 per cent (sensitivity 82 per cent, specificity 55 per cent, PPV 72 per cent, NPV 68 per cent); however, in only 53 per cent of patients was the diagnosis considered clinically unequivocal. CONCLUSION: Ultrasonography is a useful and valid modality for imaging ACD and its differential diagnoses in the hands of sonographically trained surgeons. It is especially helpful when the clinical findings are equivocal.
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A Zielke, C Hasse, C Bruns, H Sitter, M Rothmund (1997)  Octreotide: effective treatment for hyperparathyroidism? A prospective, randomized, controlled clinical trial.   Surgery 121: 6. 606-610 Jun  
Abstract: BACKGROUND: Recent studies suggest a role for somatostatin in the medical treatment of hyperparathyroidism. In a prospective, randomized, controlled, triple blinded clinical trial in patients with primary or secondary hyperparathyroidism, we evaluated the response of biochemical parameters relevant in hyperparathyroidism to the somatostatin analog octreotide. METHODS: Forty patients each with primary or secondary hyperparathyroidism were studied. Among other parameters, serum calcium and serum phosphate, parathyroid hormone, calcitonin, osteocalcin, and octreotide were assessed before and repeatedly for 4 hours after a single intravenous application of 200 micrograms octreotide or placebo. Subsequent to operation, which was performed on all patients, somatostatin-receptor autoradiography of parathyroid tissue was performed. RESULTS: After administration of octreotide, which resulted in an increase of plasma levels to pharmacologic levels, no significant changes in any of the biochemical parameters investigated for were observed. Multivariate analysis did not identify patient subpopulations that responded to either drug or placebo (p > 0.05). Forty-five percent of patients receiving octreotide reported side effects: Parathyroid tissue samples of patients with primary or secondary hyperparathyroidism were negative for somatostatin-receptor expression. CONCLUSIONS: Octreotide has no discernible effect on biochemical parameters of patients with primary or secondary hyperparathyroidism. Absence of somatostatin receptors, together with lack of octreotide effects, suggests that somatostatin is not effective in the medical therapy of hyperparathyroidism.
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A Zielke, C Hasse, T Bandorski, H Sitter, P Wachsmuth, R Grobholz, M Rothmund (1997)  Diagnostic ultrasound of acute colonic diverticulitis by surgical residents.   Surg Endosc 11: 12. 1194-1197 Dec  
Abstract: BACKGROUND: Recent studies have documented the feasibility of ultrasonography (US) to diagnose acute colonic diverticulitis (ACD). This prospective observational trial determined the sonomorphology of ACD and evaluated the diagnostic accuracy of routine US performed on admission by surgeons in training. METHODS: Fifty-seven consecutive patients with a confirmed episode of ACD were entered into this study, and the sonomorphology of the involved colon was assessed. US findings were compared to the results of the clinical evaluation and correlated to the clinicopathological outcome. RESULTS: The sonomorphology of ACD was characterized by segmental inflammatory transformation of the colon averaging 9.9 +/- 3.2 cm (range, 6-20) in length and visualized as target phenomena of a mean 3.5 +/- 0.8 cm (range, 2.4-4.8) width. Targets were caused by hypoechogenic thickening of the colonic wall of an average 7.7 +/- 2. 6 mm (range, 4-18). In 40% of cases, a hyperechogenic halo representing peridiverticulitis (average width, 2.3 +/- 0.6; range, 1.2-3 cm) was noted. Diverticula were seen in almost half of the cases. Of the 57 cases with confirmed ACD, the diagnosis was made by US in 48, for a global accuracy of 84.2%. US was false negative in nine patients, suggesting perforated appendicitis in five cases and acute appendicitis in one (the final diagnoses were perforated sigmoid diverticulitis in five cases and cecal diverticulitis in one case). In three patients, US was nondiagnostic. CONCLUSION: In the hands of sonographically trained surgeons, ultrasound is a useful modality to image acute colonic diverticulitis. US reveals diagnostic sonomorphology in most cases of ACD and therefore facilitates early confirmation of the diagnosis and assessment of severity.
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A Zielke, C Hasse, H Sitter, O Kisker, M Rothmund (1997)  "Surgical" ultrasound in suspected acute appendicitis.   Surg Endosc 11: 4. 362-365 Apr  
Abstract: BACKGROUND: Ultrasonography (US) by acknowledged experts enhances the diagnostic performance and reduces the rate of negative laparotomies in patients with suspected acute appendicitis (AA). METHODS: The diagnostic accuracy and clinical impact of routine US performed by surgical residents was prospectively studied in 504 unselected patients admitted for AA. Clinical and US findings were correlated with laparotomy findings and pathological outcome in 135 patients (113 cases with proven AA, prevalence 22.4%) and clinical as well as follow-up data were compared in the remainder. RESULTS: The overall accuracy, sensitivity, and specificity of the clinical diagnosis of AA were 84.9%, 51.3%, and 94.6% and those of US were 93. 6%, 83.1%, and 96.6%. Joint evaluation of the results from clinical evaluation and US further improved diagnostic performance (accuracy 93.4%, sensitivity 84.1%, specificity 96.2) and significantly reduced the rate of diagnostic errors to 3.4% (p < 0.001) and unnecessary laparotomies to 9.6% (p < 0.01) in patients with suspected AA. CONCLUSIONS: Ultrasonographic evaluation of the patient with suspected AA is considered to be of value in surgical practice.
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1996
C Nies, R Leppek, H Sitter, H J Klotter, J Riera, K J Klose, W B Schwerk, M Rothmund (1996)  Prospective evaluation of different diagnostic techniques for the detection of liver metastases at the time of primary resection of colorectal carcinoma.   Eur J Surg 162: 10. 811-816 Oct  
Abstract: OBJECTIVE: To evaluate preoperative and operative methods of detecting liver metastases in patients undergoing primary resection for colorectal carcinoma. DESIGN: Prospective, open study. SETTING: Teaching hospital, Germany. SUBJECTS: 51 Patients with confirmed primary colorectal carcinoma. INTERVENTIONS: Computed tomography during arterial portography (CT-AP), percutaneous ultrasonography (US), operative palpation and examination of the liver, operative US, and computed tomography (CT) follow-up 6-12 months postoperatively. MAIN OUTCOME MEASURES: Sensitivity, specificity, positive and negative predictive value, and accuracy. RESULTS: Overall accuracy was worst for CT during portography, because of the diagnosis of many false positive lesions. Exploration and palpation of the liver had the highest sensitivity (83%) and specificity (100%), and operative US did not give any useful additional information. CONCLUSIONS: Preoperative percutaneous US is recommended as the best non-invasive screening test; otherwise careful inspection and palpation during operation are sufficient for the evaluation of the liver during primary resection for colorectal carcinoma.
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1995
H Lang, A Junge, H Sitter, H J Klotter (1995)  Experimental investigation of intraoperative ultrasound in anatomically precise liver resection.   J Invest Surg 8: 4. 253-261 Jul/Aug  
Abstract: A new technique of segmental liver resection by use of intraoperative ultrasound (IOUS) and injection of methylen blue was evaluated in 15 sheep to study anatomical precision and alterations of the biochemical profile. The results were compared with those of a bisegmentectomy (n = 15) in which segmental boundaries were identified by IOUS alone. In a third group (n = 10) a sham operation (laparotomy without resection) was performed to study the intrahepatic vascular architecture of the liver by IOUS. The quality of the resections and of the ultrasound study was assessed by use of corrosion casts of the livers. The intrahepatic course of the liver veins and their confluence as well as the portal vein and its branches up to the segmental portal pedicles could be detected in all livers. Anatomically precise bisegmentectomies were achieved in 70% of IOUS combined with coloring of the segments versus only 27% in IOUS alone (p < .05). Biochemical and clinical parameters did not reveal any advantage of anatomically precise resection. The results show that intraoperative ultrasound is reliable in visualizing the intrahepatic anatomical characteristics of the liver, but it is imprecise in identifying segmental boundaries or in localizing a segment exactly. Anatomically precise liver resections are technically feasible by use of IOUS plus selective staining of the segments.
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H Lang, A Junge, H Sitter, H J Klotter, W Lorenz, M Rothmund (1995)  Liver segmentectomy as anatomically precise resections. An experimental study in sheep.   Eur J Surg 161: 9. 677-682 Sep  
Abstract: OBJECTIVE: To assess a new technique of anatomically precise hepatic segmental resection and to compare the degree of precision and biochemical profiles with results after traditional segmental resection and a sham operation. DESIGN: Experimental study. SETTING: University hospital, Germany. MATERIAL: 50 sheep (10 each had segments II, III, and IV removed by the new technique, and 10 each were studied in the traditional resection and sham operated groups). INTERVENTIONS: Operative ultrasonography and injection of methylene blue to identify segmental boundaries. In traditional operations boundaries were identified only from knowledge of the surface structure of the liver. MAIN OUTCOME MEASURES: Degree of precision, duration of operation, blood loss, mortality, transaminase activities and liver function tests. RESULTS: Anatomically precise segmentectomies were achieved in 6/9 (67%) for segment II, 6/9 (67%) for segment III, and 4/8 (50%) for segment IV. Using the traditional technique (segment III only) there was only 1/10 anatomically precise resections, together with 5 perisegmentectomies and 4 incomplete resections (p < 0.02). The operations for anatomically precise resection lasted significantly longer, but resection time was similar. Blood loss, survival, and transaminase activities were similar for the two groups, but the margin of necrosis at the cut edge was significantly less in anatomically precise resections. CONCLUSION: Anatomically precise hepatic resections are technically feasible with the use of intraoperative ultrasonography and selective staining of the segment(s) to be removed with methylene blue. Although it takes longer, there are no detrimental consequences compared with the considerably less accurate traditional technique.
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1994
W Lorenz, D Duda, W Dick, H Sitter, A Doenicke, A Black, D Weber, H Menke, B Stinner, T Junginger (1994)  Incidence and clinical importance of perioperative histamine release: randomised study of volume loading and antihistamines after induction of anaesthesia. Trial Group Mainz/Marburg.   Lancet 343: 8903. 933-940 Apr  
Abstract: Although histamine release is recognised as a common event during anaesthesia and surgery, few clinicians judge the resultant cardiorespiratory disturbances serious enough to warrant prophylaxis with antihistamines. We have assessed the incidence and importance of histamine release in a randomised 2 x 2 factorial study. 240 patients representing a routine throughput of major general surgery were studied during a standardised induction of anaesthesia and preoperative loading of the circulation with either Ringer solution or Haemaccel-35, with or without antihistamine prophylaxis with dimetindene (H1) plus cimetidine (H2). Cardiorespiratory disturbances were graded as detectable, clinically relevant, or life-threatening from observers' records of the anaesthesia and the actions taken by the anaesthetists. Disturbances that were accompanied by significant rises in plasma histamine were further designated histamine-related, and those that were not were designated histamine-unrelated. Anaesthetists, observers, and designators were blinded to whether or not the patients had received antihistamines and to which solution was used for circulatory volume loading. Clinically relevant or life-threatening histamine-related disturbances occurred in 8% of the patients who after induction of anaesthesia received Ringer without antihistamines, in 26% of those who received Haemaccel without antihistamines, and in 2% or less of those who received antihistamines (p < or = 0.0001). There were 4 life-threatening histamine-related disturbances, all in patients who received Haemaccel without antihistamines (p < 0.01). Histamine-unrelated disturbances occurred in 16% overall, with no obvious effect of Haemaccel or antihistamines. The histamine-related disturbances under anaesthesia were remarkable for their severity (even with small rises in histamine concentrations), for the prevalence of bradycardia, and for the absence of skin signs. Their likelihood and severity were increased in patients with tumours. The results of the trial make a case for routine prophylaxis with antihistamines as part of anaesthetic management.
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W Lorenz, K P Reimund, F Weitzel, I Celik, M Kurnatowski, C Schneider, W Mannheim, A Heiske, K Neumann, H Sitter (1994)  Granulocyte colony-stimulating factor prophylaxis before operation protects against lethal consequences of postoperative peritonitis.   Surgery 116: 5. 925-934 Nov  
Abstract: BACKGROUND: Postoperative peritonitis has a high mortality in human beings. It is accepted that cytokines are important mediators in pathophysiology of sepsis. The recent failure of clinical trials increased the necessity to proof new drugs in more clinically relevant animal models. The aim of this study was to examine the effect of granulocyte colony-stimulating factor (G-CSF) in addition to an antibiotic in postoperative peritonitis. METHODS: Dose-response curves and experimental conditions were developed in a total of 295 rats. The main experiment included three groups: control animals receiving a fecal inoculum, a group treated with antibiotic, and a third group receiving G-CSF in addition to the antibiotic. The main outcome was death, but in addition, serum tumor necrosis factor (TNF) level was determined. RESULTS: The mortality rate of 60% in antibiotic treated animals was considerably reduced by G-CSF to 20%. All animals of the control group died during the observation period of 120 hours. A correlation between TNF levels and mortality rate was observed. In G-CSF treated animals total suppression of TNF serum levels was accessible in contrast to the others. CONCLUSIONS: In a clinically relevant animal model G-CSF was effective as an additional concept of prophylaxis. These data are promising toward clinical trials.
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C Nies, H Sitter, A Zielke, T Bandorski, J Menze, K Ehlenz, M Rothmund (1994)  Parathyroid function following ligation of the inferior thyroid arteries during bilateral subtotal thyroidectomy.   Br J Surg 81: 12. 1757-1759 Dec  
Abstract: A randomized controlled trial was performed to compare two techniques of bilateral subtotal thyroidectomy for non-toxic nodular goitre with regard to postoperative parathyroid function. The 50 patients in group 1 underwent ligation of the trunks of the inferior thyroid arteries. In group 2 (50 patients) the branches of these arteries were suture-ligated at the thyroid capsule. Total calcium, ionized calcium and parathyroid hormone levels were determined before operation, and 6, 24 and 72 h after surgery. Ninety-one patients were seen at follow-up 5-10 months after operation. Ten patients in group 1 and 12 in group 2 required calcium and/or vitamin D supplementation for symptomatic hypocalcaemia in the immediate postoperative period. At follow-up only one patient in each group had mild hypoparathyroidism. No statistically significant differences were found between groups regarding total calcium, ionized calcium and parathyroid hormone levels. Truncal ligation of the inferior thyroid arteries during bilateral subtotal thyroidectomy does not cause hypoparathyroidism or hypocalcaemia.
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1993
D Duda, W Lorenz, H Menke, B Stinner, C Hasse, C Nies, U Schäfer, H Sitter, T Junginger, M Rothmund (1993)  Perioperative nonspecific histamine release: a new classification by aetiological mechanisms and evaluation of their clinical relevance.   Ann Fr Anesth Reanim 12: 2. 147-165  
Abstract: As a consequence of the performance of a randomized controlled clinical trial on perioperative histamine release and cardiovascular and respiratory disturbances, several types of increases in plasma histamine had to be distinguished instead of only two which existed at the beginning of the study: drug-induced allergic and pseudoallergic reactions. First of all, the new classification by aetiology (clinical epidemiology) was derived from a meta-analysis (secondary analysis) of the most recent literature. According to that histamine release in the perioperative period has several, different causes and is involved in several, different disease manifestations. A clear distinction (classification), however, is necessary if histamine release as an unwanted (adverse) effect has to be recognized, value judged according to its clinical relevance and therefore also prevented by histamine antagonists. Histamine release by neuro-endocrine and neuro-inflammatory mechanisms, cytotoxic histamine release and local, cytokine induced histamine release have been distinguished from pseudoallergic histamine release, but its functions are not yet clear. It has been analysed in prospective trials which used special clinical situations as models: patients on a normal ward or before and during upper GI endoscopy without premedication, but also in specific phases of laparoscopic cholecystectomy (trocar phase and dissection phase). Their existence in the clinical reality is now very likely, but new trials must investigate the pathophysiological effects such as in metabolism, coagulation, pulmonary haemodynamics (shunt volume) and gastric acid secretion. Histamine release by pseudoallergic mechanisms, however, was identified in the very vulnerable post-induction phase of anaesthesia up to skin incision. Its incidence was much higher than ever expected and its clinical relevance was demonstrated by the severity of reactions and the intervention strategies of the anaesthetists who were blinded concerning the type of the plasma substitute given and the prophylaxis with antihistamines. Pseudoallergic histamine release was clearly unwanted (adverse). Its occurrence in the other phases of anaesthesia has to be further evaluated in the tedious procedure of data analysis of the Mainz-Marburg-trial. The overall incidence of histamine release in the trial was so incredible high (72% of all patients, some of them with up to 4 episodes of histamine release) that a distinction between pseudoallergic (unwanted) and other types of histamine release (possibly less unwanted or even beneficial) is urgently needed. In the phase of steady state (maintenance) of anaesthesia the H1-(+)H2-prophylaxis was highly effective. Further analysis must show whether this is also the case during the phases of induction of anesthesia.(ABSTRACT TRUNCATED AT 400 WORDS)
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1992
W Dick, W Lorenz, D Heintz, H Sitter, A Doenicke (1992)  Histamine release during induction of combination anesthesia using nalbuphine or fentanyl. Modulation of the reaction by premedication with promethazine/pethidine   Anaesthesist 41: 5. 239-247  
Abstract: In a controlled clinical trial in patients admitted for general surgery (mainly abdominal and thyroid), histamine release following nalbuphine 1 mg/kg i.v. versus fentanyl 5 micrograms/kg i.v. was studied in the course of an otherwise routine induction with promethazine/pethidine as premedication 30 min before the opioids and alcuronium-flunitrazepam-thiopental 5 min later. Succinylcholine was given before intubation and further analgesia was obtained by repeated administration of either nalbuphine or fentanyl. Plasma histamine levels were measured by a specific fluorometric assay, heart rate and blood pressure were measured for assessing hemodynamics, and clinical signs of anaphylactoid reactions such as skin eruptions and arrhythmias were registered. RESULTS. Nalbuphine and fentanyl both released histamine with an incidence of more than 40%. In addition, nalbuphine potentiated the histamine release evoked by the sequential administration of alcuronium-flunitrazepam-thiopental in one complex of application. The incidence of histamine release in the nalbuphine group was 6/13 = 46%, in the fentanyl group only 1/11 = 9% (chi2 test, P less than 0.05). Furthermore, this study showed high histamine levels after succinylcholine and intubation in a relation to time of administration that suggested histamine release as a stress response to intubation. Finally, the incidence of histamine release after a second injection of the opioids was still 30%. A direct correlation between plasma histamine levels, hemodynamic changes, and skin reactions could not be shown. A detailed causality analysis with histamine release as a contributory determinant showed histamine release less detrimental to hemodynamic stability than the opposite, which had been expected. However, the promethazine administered 30 min before induction of anaesthesia had strong H1- and H2-receptor antagonistic activity and was given with optimum timing for H1- and H2-prophylaxis. CONCLUSION. The study demonstrated that histamine release during anaesthesia and surgery depends strongly on the time sequence of drugs and measures used. Histamine release is not predictable from studies in human volunteers alone; studies in patients have to be added. Histamine release is not always detrimental. H3-receptor-mediated effects after H1- and H2-prophylaxis may help patients to counteract the effects of a series of vasoactive drugs given during induction of anaesthesia.
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C Ohmann, M Kraemer, S Jäger, H Sitter, C Pohl, B Stadelmayer, P Vietmeier, J Wickers, L Latzke, B Koch (1992)  Acute abdominal pain--standardized findings as diagnostic support. Results of a prospective multicenter intervention study and testing of a computer-assisted diagnosis system   Chirurg 63: 2. 113-22; discussion 122-3 Feb  
Abstract: Despite powerful diagnostic tools (e.g. ultrasound, special laboratory investigations), the diagnosis of acute abdominal pain is still a considerable problem. Several studies in the UK have shown that the diagnostic accuracy can be improved by structured and standardized history taking and clinical examination and by computer-aided diagnosis. In the framework of a concerted action of the European Community we have conducted a prospective multicenter interventional trial comparing two consecutive phases: a) a baseline phase in clinical routine without additional intervention, b) a test phase with structured and standardized history and clinical examination (questionnaire, documentation programme). In addition, a computer-aided diagnostic system developed in the UK was applied to the cases in the test phase. Outcome criteria were the diagnostic accuracy of the initial and the final examiner, the perforated appendix rate, the negative appendectomy rate, the negative laparotomy rate and the rates of diagnostic errors with missing indication to operation and of delayed urgent operations. No differences could be found between the phases with respect to the outcome criteria. In the baseline phase (test phase) diagnostic accuracy was 59% (59%), diagnostic accuracy after investigation (senior examiner) was 77% (78%), perforated appendix rate was 11% (16%), negative appendectomy rate was 13% (15%), negative laparotomy rate was 7% (8%), the rate of missed urgent indications to operation was 1.1% (1.9%) and the rate of delayed urgent operations was 3.4% (2.4%). Major differences between the centers were recorded. Computer-aided diagnosis resulted in a diagnostic accuracy of 51%. The introduction of structured and standardized history taking and clinical examination has not brought any improvement of the good results in clinical routine. It is doubtful, whether existing systems of computer-aided diagnosis are able to significantly decrease the still remaining error rate of 20%.
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H Lill, H Sitter, H J Klotter, C Nies, K Güntert-Gömann, M Rothmund (1992)  What is the cost of laparoscopic cholecystectomy?   Chirurg 63: 12. 1041-1044 Dec  
Abstract: After laparoscopic cholecystectomy (LC) has replaced open cholecystectomy (OC) to a large extent as standard method in the operative treatment of cholecystolithiasis the question of costs and economics raises. To evaluate this question the data of 50 patients who underwent elective LC were analysed in a retrospective study and compared with the data of 50 patients who were cholecystectomized using the open technique. The median of in-hospital stay was 6 (3-15) days for LC and 10 (3-33) days for OC. The median of time of working-disability was 14 (2-35) days for LC and 21 (2-56) days for OC. Total cost (median) of 3788 (2637-8101) DM for LC compared to 4509 (2041-15218) DM for OC. The median of hospital income was 2790 (1395-6975) DM for the LC-group and 4650 (1395-15346) DM for the OC-group. Due to the shorter in-hospital stay of LC-patients this method causes a microeconomical loss for the hospital compared to OC. Macroeconomically LC represents a benefit because of shorter working-disability.
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H Printz, H J Klotter, C Nies, C Hasse, M Neurath, H Sitter, M Rothmund (1992)  Intraoperative ultrasonography in surgery for chronic pancreatitis.   Int J Pancreatol 12: 3. 233-237 Dec  
Abstract: We report our experience with intraoperative ultrasonography in 49 patients undergoing surgery for chronic pancreatitis. Among drainage procedures, there were 14 laterolateral pancreaticojejunostomies, 15 pseudocystojejunostomies, and 2 pseudocystoduodenostomies. Under the guidance of intraoperative ultrasonography, left sided partial resection of the pancreas was performed in 7 patients, whereas a Whipple-type procedure was necessary in 6 cases. All preoperatively diagnosed pseudocysts, abscess formations, and dilated pancreatic ductal systems could be easily localized with the assistance of intraoperative ultrasound. Additionally to diagnoses already made preoperatively, intraoperative ultrasonography revealed a second, smaller pseudocyst in one patient and pancreaticolithiasis in another case. However, significant assistance and comfort to the operating surgeon was provided in all cases by intraoperative ultrasound imaging. This technique, which is cost effective and minimally invasive, proved to be extremely helpful in localizing pancreatic fluid collections and the course of the pancreatic duct. It facilitates the operation by reducing tissue traumatization and operative time. In experienced hands, intraoperative ultrasonography is a reliable method and a useful adjunct to the surgeon.
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1991
W Lorenz, H Sitter, B Stinner, D Duda, B Kapp, B Gstrein, W Dietz, A Doenicke, W Dick (1991)  Controlled clinical trials and cross-sectional studies with plasma histamine measurements and histamine receptor antagonists: solving the problem of preoperative H1- + H2-prophylaxis by asking new questions?   Agents Actions Suppl 33: 197-230  
Abstract: The problem of a preoperative histamine H1- + H2 - prophylaxis was tackled by a group of new studies including randomized controlled clinical trials and cross-sectional studies with plasma histamine measurements and administration of H1- + H2 - antagonists to a control group. The first study demonstrated serial histamine release in the induction of anaesthesia up to 4 times in a single patient. Basal plasma histamine levels in resting subjects fell below 100 pg/ml during the time necessary for preparation of the surgical patient. Hence, spikes of elevated plasma histamine concentrations corresponded to histamine release. Although this histamine release very often was less than 1 ng/ml plasma histamine, it created systemic reactions after atracurium. The cut-off point of 1 ng/ml for such anaphylactoid reactions does no longer exist, also lower plasma levels are of patho-physiological significance. The clinical signs of histamine release in the induction of anaesthesia vary from drug to drug. Sometimes tachycardia and hypertension produce the highest likelihood ratio, sometimes tachy- and bradycardia, but no changes in blood pressure as in the case of atracurium. It is concluded that the reasons why histamine release in anaesthesia and surgery is so much underreported and under-estimated include the present paradigms about plasma histamine levels and the "classical picture" of histamine release. Both are no longer valid and need a re-assessment.
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P Dünninger, J Einwag, H Sitter (1991)  Reproducibility of measurements to assess the quality of dental restorations   Dtsch Zahnarztl Z 46: 3. 212-214 Mar  
Abstract: Criteria for assessment of the quality of dental restorations should be highly reproducible. To prove reproducibility of a set of modified Ryge-criteria we assessed the quality of 468 fillings (157 amalgam, 155 cast restorations, 156 composites). Assessment was done double-blind by two investigators. The amount of agreement between the investigators ranged from 56.1% to 88.4% depending on the criteria used. The more positive the results of the assessment and the more objectifiable the criteria, the higher was the amount of agreement. For an objective assessment the reproducibility of the method seems to be unsatisfactory.
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H Sitter, W Lorenz, H J Klotter, D Duda, G Buess, J Sattler (1991)  Elevated plasma histamine concentration as a sensitive real-time parameter for distinct phases of surgical trauma: a tool for technology assessment.   Agents Actions 33: 1-2. 203-207 May  
Abstract: High technology plays an important role in surgery, either to expand surgical procedures or to reduce tissue trauma, which is a main goal of minimum invasive surgery. Due to the tremendous increase of costs the problem of technology assessment will not only be solved by statistical methods, but also by biomedical considerations and laboratory tests. Histamine release could be an indication for tissue trauma, which is caused directly by tissue damage or indirectly by infection or hypoxia. Therefore histamine release was investigated during different phases of operation in two clinically very important and complex situations: resection of liver metastases of colorectal carcinoma and resection of the oesophagus because of an oesophageal carcinoma. To model this situation in animal experiments, two randomized controlled studies were conducted in sheep. Traditional techniques were compared with techniques of minimum invasive surgery. Plasma histamine levels were determined at well-defined phases of the operation. Histamine release was demonstrated at distinct phases of operation indicating considerable specificity of this parameter, if sensitivity is guaranteed by advanced tests. Incision of the liver capsule by thermocauterization, liver ischaemia, tissue trauma in more extended disruption of perioesophageal tissue were causes of more extended histamine release. It is concluded that measurement of plasma histamine is a suitable indicator for discriminating between extended and minimum invasive surgery. The consequence of considering this parameter may be less complications in the post-operative period and a short hospital stay with better quality of life.
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A Zielke, U Malewski, R Lindlar, R Förster, H J Klotter, J Rüschoff, H Sitter, M Rothmund (1991)  Ultrasonic diagnosis in suspected acute appendicitis: probable or certain indications for surgery?   Chirurg 62: 10. 743-749 Oct  
Abstract: The diagnostic accuracy and the clinical impact of routine ultrasonography performed by 4 surgeons, were prospectively studied in 366 unselected patients admitted for suspected acute appendicitis. Clinical and sonographic findings on admission were correlated with laparotomy findings, pathological outcome and clinical as well as follow-up data. The overall sensitivity, specificity and accuracy of the clinical diagnosis of acute appendicitis were 55.3%, 94.6% and 84.2% respectively (positive predictive value (PPV) 75.8%, negative predictive value (NPV) 87.3%). Ultrasound enabled visualization of the disease in 67 of 85 (prevalence 23.3%) patients with a histologically confirmed acute appendicitis; false positive results were recorded in 7 cases (sensitivity 78.8%, specificity 97.5%, accuracy 93.1%, PPV 90.5%, NPV 93.8%). Ultrasound was particularly useful in patients presenting with equivocal or highly unsuspective signs of acute appendicitis: of 38 patients with an acute appendicitis in this group ultrasonography enabled to make the diagnosis in 26. The combined approach of clinical evaluation and routine ultrasonography markedly improved the diagnostic accuracy (sensitivity 85.9%, specificity 96.4%, accuracy 94%) and substantially reduced the negative laparotomy rate (7.9%) in patients with suspected acute appendicitis. It is concluded, that ultrasonographic evaluation of the patient with suspected acute appendicitis performed by surgeons is of great assistance in surgical practice.
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1990
W U Schmidt, J Sattler, R Hesterberg, H D Röher, T Zoedler, H Sitter, W Lorenz (1990)  Human intestinal diamine oxidase (DAO) activity in Crohn's disease: a new marker for disease assessment?   Agents Actions 30: 1-2. 267-270 Apr  
Abstract: The key-enzyme for the metabolism of diamines in man is diamine oxidase (DAO). Its highest activities are in the intestinal mucosa, localized in the cytoplasm of the mature enterocytes of the small and large bowel. If the gut is affected by inflammation in Crohn's disease macroscopical changes are observed. This prospective study investigated if these mucosal alterations are also reflected in changes of mucosal diamine oxidase activity and/or mucosal histamine content respectively. Twenty patients (12 female, 8 male; age: means = 31, range 18-49 years) undergoing gut resection because of complications in Crohn's disease (Jan.-Dec. 1988) formed the basis of the study. Tissue samples of the resected material from areas inflamed and histologically not involved in the disease were investigated for diamine oxidase activities and histamine content. Diamine oxidase activities in the mucosa obtained from the macroscopically normal proximal (155.6; (76-393) mU/g (means, range)) and distal (132; (58.5-295) mU/g) resection margins were similar to our previous findings. In all patients, however, samples from the diseased mucosa had significantly (ca. 50%) lower diamine oxidase activities (74.5; (5-262) mU/g) compared to the healthy tissue. Similar differences were found in material obtained either from whole intestinal wall or from the mucosa. The determination of diamine oxidase activity constitutes possibly a more unambiguous and earlier parameter for assessing the extent of the inflamed area than histological disease presentations. Using biopsies the necessary extent of resection could be estimated before operation: this may influence operative strategies and help in the definition of the minimum amount of inflamed gut to be removed.
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P K Wagner, A Ramaswamy, H Sitter, J Rüschoff, P Schmitz-Moormann (1990)  Normal value of the number of lymph nodes in the epigastrium. An anatomic study for lymphadenectomy in stomach cancer   Chirurg 61: 4. 286-288 Apr  
Abstract: The number of regional lymph nodes relevant for lymphadenectomy in gastric cancer was investigated in an autopsy study. In group N1-16 as described by JRSGC on the average 43 lymph nodes were found (range 25 to 64 lymph nodes). For group N1-11 (R1 and R2 resection, compartments I and II respectively) 27 lymph nodes were found on the average (range 17 to 44 lymph nodes). The results differed considerably in total number as well as within each single group and in the groups N1-16/N1-11. These results can be taken as statistical standard values.
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1985
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