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Lehmann K.S.,Charité - Medical University of Berlin | Ritz J.P.,Charité - Medical University of Berlin | Wibmer A.,Charité - Medical University of Berlin | Gellert K.,Sana Klinikum Lichtenberg | And 13 more authors.
Annals of Surgery | Year: 2010

Objective: To analyze patient outcome in the first 14 months of the German natural orifice translumenal endoscopic surgery (NOTES) registry (GNR). Summary background data: NOTES is a new surgical concept, which permits scarless intra-abdominal operations through natural orifices, such as the mouth, vagina, rectum, or urethra. The GNR was established as a nationwide outcome database to allow the monitoring and safe introduction of this technique in Germany. Methods: The GNR was designed as a voluntary database with online access. All surgeons in Germany who performed NOTES procedures were requested to participate in the registry. The GNR recorded demographical and therapy data as well as data on the postoperative course. Results: A total of 572 target organs were operated in 551 patients. Cholecystectomies accounted for 85.3% of all NOTES procedures. All procedures were performed in female patients using transvaginal hybrid technique. Complications occurred in 3.1% of all patients, conversions to laparoscopy or open surgery in 4.9%. In cholecystectomies, institutional case volume, obesity, and age had substantial effect on conversion rate, operation length, and length of hospital stay, but no effect on complications. Conclusions: Despite the fact that NOTES has just recently been introduced, the technique has already gained considerable clinical application. Transvaginal hybrid NOTES cholecystectomy is a practicable and safe alternative to laparoscopic resection even in obese or older patients. Copyright © 2010 by Lippincott Williams & Wilkins.


Urban P.P.,Asklepios Klinik Barmbek | Wellach I.,Asklepios Klinik Barmbek | Faiss S.,Gastroenterology | Layer P.,Israelitisches Krankenhaus | Weis J.,RWTH Aachen
Movement Disorders | Year: 2010

We describe two patients who developed subacute axonal peripheral neuropathy under duodopa treatment. Comprehensive diagnostic workup including muscle and sural nerve biopsy revealed that the most probable cause of subacute axonal peripheral neuropathy was cobalamin and vitamin B6 deficiency in both the patients. © 2010 Movement Disorder Society.


PubMed | Israelitisches Krankenhaus, University of Leipzig, Deutsche Klinik fur Diagnostik, Klinikum Braunschweig and 10 more.
Type: Comparative Study | Journal: Gut | Year: 2016

To investigate the efficacy and safety of two different budesonide formulations (effervescent tablet for orodispersible use (BET) and viscous suspension (BVS)) with different daily dosages for short-term treatment of eosinophilic oesophagitis (EoE).Adults with active EoE (n=76) randomly received 14days treatment with either BET 21mg/day (BET1, n=19) or BET 22mg/day (BET2, n=19), or BVS 25mL (0.4mg/mL)/day (BVS, n=19) or placebo (n=19) in a double-blind, double-dummy fashion, with a 2-week follow-up. Primary end point was histological remission (mean of <16eosinophils/mm(2)hpf). Secondary end points included endoscopy score, dysphagia score, drug safety and patients preference for drug formulation.Histological remission occurred in 100%, 94.7% and 94.7% of budesonide (BET1, BET2, BVS, respectively) and in 0% of placebo recipients (p<0.0001). The improvement in total endoscopic intensity score was significantly higher in the three budesonide groups compared with placebo. Dysphagia improved in all groups at the end of treatment; however, improvement of dysphagia persisted only in those treated with BET1 (p=0.0196 vs placebo). There were no serious adverse events. Local fungal infection (stained fungi) occurred in two patients of each budesonide group (10.5%). The effervescent tablet was preferred by 80% of patients.BET or BVS was highly effective and safe for short-term treatment of EoE. The 1mg (twice daily) dosage was equally effective as the 2mg twice daily dosage. The majority of patients preferred the effervescent tablet formulation.NCT02280616; EudraCT number, 2009-016692-29.


Miehlke S.,Center for Digestive Diseases Eppendorf | Hruz P.,University of Basel | Vieth M.,Institute for Pathology | Bussmann C.,Institute for Pathology | And 15 more authors.
Gut | Year: 2016

Objective: To investigate the efficacy and safety of two different budesonide formulations (effervescent tablet for orodispersible use (BET) and viscous suspension (BVS)) with different daily dosages for short-term treatment of eosinophilic oesophagitis (EoE). Design: Adults with active EoE (n=76) randomly received 14 days' treatment with either BET 2×1 mg/day (BET1, n=19) or BET 2×2 mg/day (BET2, n=19), or BVS 2×5 mL (0.4 mg/mL)/day (BVS, n=19) or placebo (n=19) in a double-blind, double-dummy fashion, with a 2-week follow-up. Primary end point was histological remission (mean of <16 eosinophils/mm2 hpf). Secondary end points included endoscopy score, dysphagia score, drug safety and patient's preference for drug formulation. Results: Histological remission occurred in 100%, 94.7% and 94.7% of budesonide (BET1, BET2, BVS, respectively) and in 0% of placebo recipients (p<0.0001). The improvement in total endoscopic intensity score was significantly higher in the three budesonide groups compared with placebo. Dysphagia improved in all groups at the end of treatment; however, improvement of dysphagia persisted only in those treated with BET1 (p=0.0196 vs placebo). There were no serious adverse events. Local fungal infection (stained fungi) occurred in two patients of each budesonide group (10.5%). The effervescent tablet was preferred by 80% of patients. Conclusions: BET or BVS was highly effective and safe for short-term treatment of EoE. The 1 mg (twice daily) dosage was equally effective as the 2 mg twice daily dosage. The majority of patients preferred the effervescent tablet formulation. ClinicalTrials.gov number: NCT02280616; EudraCT number, 2009-016692-29.


PubMed | Israelitisches Krankenhaus and University of Hamburg
Type: Journal Article | Journal: Zeitschrift fur Gastroenterologie | Year: 2016

To date there is no study that has estimated the prevalence of irritable bowel syndrome (IBS) in Germany according to the current Rome III criteria. The aim of the present study was to investigate the prevalence of IBS in a non-clinical German sample. Furthermore, we investigated the association of IBS with socio-demographic and psychological risk factors.Baseline data from a prospective cohort study were analysed, including the IBS Module of the Rome III Diagnostic Questionnaires and validated psychometric scales including the Patient Health Questionnaire-15 (PHQ-15), the Big Five Inventory (BFI), the Perceived Stress Questionnaire (PSQ-5), and the Whiteley-Index (WI-7). The study population was compared to the German general population to appraise its representativeness. Multivariate logistic regression analyses were performed to identify possible risk factors associated with IBS.Between January 2011 and September 2012, 2419 persons participated (female 54.0%, mean age 37.414.9 years). According to the Rome III criteria, 401 participants (16.6%) suffered from IBS.Five predictors were independently associated with IBS: previous travellers diarrhoea infection (OR=1.76; 95% CI=1.34 to 2.31), higher somatic symptom burden (OR=1.15; 95% CI=1.07 to 1.23), increased level of hypochondriasis (OR=2.04; 95% CI=1.54 to 2.70), increased vulnerability to diarrhoea under stress (OR=3.88; 95% CI=3.21 to 4.68) and perceived stress (OR=1.43; 95% CI=1.04 to 1.99).Our analyses yielded a relatively high IBS prevalence estimate, compared to studies published more than ten years ago. This might partially be explained by the fact that the time criterion of the Rome III criteria (at least 3 days/month in last 3 months) is more inclusive compared to the time criterion of the Rome II criteria (at least 12 weeks, which need not be consecutive, in the preceding 12 months).


Fuchs K.H.,AGAPLESION Markus Krankenhaus | Meining A.,TU Munich | Von Renteln D.,Universitatskrankenhaus Eppendorf | Fernandez-Esparrach G.,University of Barcelona | And 3 more authors.
Surgical Endoscopy and Other Interventional Techniques | Year: 2013

Background: The concept of natural orifice transluminal endoscopic surgery (NOTES) consists of the reduction of access trauma by using a natural orifice access to the intra-abdominal cavity. This could possibly lead to less postoperative pain, quicker recovery from surgery, fewer postoperative complications, fewer wound infections, and fewer long-term problems such as hernias. The Euro-NOTES Foundation has organized yearly meetings to work on this concept to bring it safely into clinical practice. The aim of this Euro-NOTES status update is to assess the yearly scientific working group reports and provide an overview on the current clinical practice of NOTES procedures. Methods: After the Euro-NOTES meeting 2011 in Frankfurt, Germany, an analysis was started regarding the most important topics of the European working groups. All prospectively documented information was gathered from Euro-NOTES and D-NOTES working groups from 2007 to 2011. The top five topics were analyzed. Results: The statements of the working group activities demonstrate the growing information and changing insights. The most important selected topics were infection issue, peritoneal access, education and training, platforms and new technology, closure, suture, and anastomosis. The focus on research topics changed over time. The principle of hybrid access has overcome the technical and safety limitations of pure NOTES. Currently the following NOTES access routes are established for several indications: transvaginal access for cholecystectomy, appendectomy and colon resections; transesophageal access for myotomy; transgastric access for full-thickness small-tumor resections; and transanal/transcolonic access for rectal and colon resections. Conclusions: NOTES and hybrid NOTES techniques have emerged for all natural orifices and were introduced into clinical practice with a good safety record. There are different indications for different natural orifices. Each technique has been optimized for the purpose of finding a safe and realistic solution to perform the procedure according to the specific indication. © 2013 Springer Science+Business Media New York.


Mofid H.,Israelitisches Krankenhaus | Emmermann A.,Israelitisches Krankenhaus | Alm M.,Israelitisches Krankenhaus | Von Waldenfels H.-A.,Praxisklinik Winterhude for Gynecology and Obstetrics | And 2 more authors.
Surgical Endoscopy and Other Interventional Techniques | Year: 2013

Background: Since 2007, natural orifice transluminal endoscopic surgery (NOTES) has been applied in humans. We performed this prospective study to evaluate the transvaginal route in terms of risks, complication rate, and long-term side effects such as dyspareunia. Methods: From June 2007 to September 2011, we performed 222 transvaginal hybrid NOTES procedures: 220 transvaginal cholecystectomies (TVC) and 2 transvaginal appendectomies (TVA). All patients were asked to present to our associated gynecologists within 1 week for an examination. After at least 3 months, the patients were interviewed using a standard questionnaire. Results: All operations could be successfully performed in this technique except two cases, which were converted to conventional laparoscopic cholecystectomy. The only intraoperative complication was the puncture of the urine bladder. We observed two postoperative complications: one biliary fistula 3 days after TVC, and one abscess in the Douglas pouch 3 weeks after TVC. The gynecological examinations revealed no abnormalities. The interview (median postoperative time, 6 months) with a follow-up rate of 93 % revealed no pain in the pelvis, dyspareunia, or sexual dysfunction after TVC. Conclusions: The transvaginal route is appropriate for NOTES procedures; there is only a minor and acceptable rate of intra- and postoperative morbidity. © 2013 Springer Science+Business Media New York.


Zornig C.,Israelitisches Krankenhaus | Siemssen L.,Israelitisches Krankenhaus | Emmermann A.,Israelitisches Krankenhaus | Alm M.,Israelitisches Krankenhaus | And 3 more authors.
Surgical Endoscopy and Other Interventional Techniques | Year: 2011

Background Natural orifice transluminal endoscopic surgery (NOTES) is currently a very important topic for both gastroenterologists and surgeons. We have developed a technique of transvaginal hybrid NOTES cholecystectomy (TVC) that leaves no visible scar and is applicable to daily use. This technique is compared to the conventional laparoscopic cholecystectomy (CLC) in a matched-pair analysis. Methods From June 2007 until February 2009, 108 NOTES cholecystectomies were performed. For a matchedpair analysis we first selected a group of 192 female patients who had undergone CLC and who were operated on by the same group of surgeons in the same time period. Then 108 pairs who had TVC were matched according to the degree of inflammation of the gallbladder and age. We were able to contact 208 patients at least 3 months after surgery. Hence, the study analysis was performed with 100 complete pairs. Results All 200 cholecystectomies were performed successfully without conversion. The TVC procedure was significantly longer than CLC (52 vs. 35 min, p<0.001). There were no intraoperative complications in either group. There were no significant differences with respect to reoperations, wound infections, consumption of analgesic drugs, length of hospital stay, and sick leave. Seventy-five TVC and 73 CLC patients had sexual intercourse after the operation without any complaints. Conclusion We present here the largest series of NOTES for cholecystectomy published to date and the first comparative study with the gold standard. The TVC technique is as successful as the CLC, it causes no more complications than CLC, especially with respect to the vaginal approach, it is more time-consuming to perform, but has an ideal cosmetic result, i.e., no visible scar. © Springer Science+Business Media, LLC 2010.


Wenck C.,Israelitisches Krankenhaus | Zornig C.,Israelitisches Krankenhaus
Langenbeck's Archives of Surgery | Year: 2010

This article and video presents our Toupet procedure. It is a modern adaptation of Toupet's original technique. Toupet described his technique of fundoplication in 1963 (Toupet, Mem Aca Chir 89:394, 1963). He had little experience but saw the importance of a partial wrap to avoid postoperative dysphagia. He recommended closure of the hiatus only in case of large hernias and never divided the short gastric vessels. If we talk about a Toupet procedure today, we mean a posterior partial fundoplication. In contrary to his original technique, we have learned that hiatal closure is important to avoid recurrent hernia and that the wrap in most cases can be tailored more nicely if the short gastric vessels are divided. This modern adaptation of the Toupet's operation is a very successful tool to treat gastro-oesophageal reflux disease. © Springer-Verlag 2010.


Mofid H.,Israelitisches Krankenhaus | Emmermann A.,Israelitisches Krankenhaus | Alm M.,Israelitisches Krankenhaus | Zornig C.,Israelitisches Krankenhaus
Langenbeck's Archives of Surgery | Year: 2013

Purpose: Transvaginal specimen removal has been introduced 20 years ago but then abandoned. With the advent of transvaginal interventions following the introduction of natural orifice transluminal endoscopic surgery, renewed interest was generated for hybrid procedures with minimal access for the intervention and use of transvaginal (TV) specimen removal. We present the first such series after laparoscopic distal pancreatectomy. Methods: In seven subsequent women (median age 48 years) with body and tail pancreatic tumors undergoing laparoscopic distal pancreatectomy, the new method of TV specimen removal was applied. The patients' data and the technical successes as well as intra- and postprocedural complications were recorded prospectively. The patients were followed after discharge for gynecological examination. Results: Specimen removal consisting of the pancreas and spleen in five and the pancreas only in two cases was technically successful; no intraoperative complications were encountered. Postoperative complications consisted of one case of intra-abdominal hemorrhage and one case of pancreatic fistula, attributable to the resection and not to TV specimen removal. Gynecological follow-up was normal in all seven patients. Conclusions: The technique of TV specimen removal is feasible and safe also after laparoscopic distal pancreatectomy. It may help to further diminish the access trauma of laparoscopic pancreatic surgery. © 2013 Springer-Verlag Berlin Heidelberg.

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