Carolin Cordewener1, Manuel Zürcher2, Philip C Müller3, Beat P Müller-Stich4, Andreas Zerz5, Georg R Linke2, Daniel C Steinemann6,7. 1. Pelvic Floor Unit, Clarunis, University Center for Gastrointestinal and Liver Diseases, 4002, Basel, Switzerland. 2. Department of Surgery, Spital Thun STS AG, Krankenhausstrasse 12, 3600, Thun, Switzerland. 3. Department of Visceral and Transplantation Surgery, University Hospital Zürich, Rämistrasse 100, 8032, Zurich, Switzerland. 4. Department of Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. 5. eSwiss Medical and Surgical Center, Klinik Stephanshorn, Brauerstrasse 97, 9016, St. Gallen, Switzerland. 6. Pelvic Floor Unit, Clarunis, University Center for Gastrointestinal and Liver Diseases, 4002, Basel, Switzerland. Daniel.steinemann@unibas.ch. 7. Medical Faculty, University Basel, Klingelbergstrasse 61, 4056, Basel, Switzerland. Daniel.steinemann@unibas.ch.
Abstract
BACKGROUND:Transrectal Natural Orifice Transluminal Endoscopic Surgery is currently limited by the inherent risk of surgical site infection due to peritoneal contamination after rectotomy. Coloshield has been developed as a temporary colon occlusion device to facilitate rectal washout. However, effectiveness and safety has not been evaluated in humans. METHODS: Twenty-two patients have been randomly assigned to undergo proctological intervention with a rectal washout with and without the use of Coloshield. Patients and assessors were blinded. Boston Bowel Preparation Scale (BBPS) has been determined 30 min as well as immediately after rectal washout. Feasibility, pain, intra- and postoperative morbidity as well as bowel function and continence 6 weeks after surgery were assessed. RESULTS:BBPS 30 min after rectal washout with and without Coloshield was in mean 2.42 ± 1.02 and 2.12 ± 0.89 (p = 0.042). Mean BBPS immediately after rectal washout was 2.39 ± 1.02 and 2.24 ± 0.66 (p = 0.269). Mean BBPS immediately after rectal washout and 30 min thereafter did not differ (p = 0.711). Coloshield application was feasible without any complications. The median (interquartile range) numeric rating scale for pain 4 h after surgery was 1 (0-1) and 3 (0-4) (p = 0.212). Six weeks after surgery 0/11 and 1/11 patients suffered from evacuation difficulties (p = 1.0) and the median Vaizey-Wexner score was 1 (0-3) and 1 (0-2) (p = 0.360). CONCLUSIONS: Coloshield application in humans is feasible and safe. Slight benefits in rectal preparation by washout are found when Coloshield is used. Colon occlusion by Coloshield for transrectal NOTES should be evaluated within clinical studies. TRIAL REGISTRATION: Clinicaltrials.gov NCT02579330.
RCT Entities:
BACKGROUND: Transrectal Natural Orifice Transluminal Endoscopic Surgery is currently limited by the inherent risk of surgical site infection due to peritoneal contamination after rectotomy. Coloshield has been developed as a temporary colon occlusion device to facilitate rectal washout. However, effectiveness and safety has not been evaluated in humans. METHODS: Twenty-two patients have been randomly assigned to undergo proctological intervention with a rectal washout with and without the use of Coloshield. Patients and assessors were blinded. Boston Bowel Preparation Scale (BBPS) has been determined 30 min as well as immediately after rectal washout. Feasibility, pain, intra- and postoperative morbidity as well as bowel function and continence 6 weeks after surgery were assessed. RESULTS: BBPS 30 min after rectal washout with and without Coloshield was in mean 2.42 ± 1.02 and 2.12 ± 0.89 (p = 0.042). Mean BBPS immediately after rectal washout was 2.39 ± 1.02 and 2.24 ± 0.66 (p = 0.269). Mean BBPS immediately after rectal washout and 30 min thereafter did not differ (p = 0.711). Coloshield application was feasible without any complications. The median (interquartile range) numeric rating scale for pain 4 h after surgery was 1 (0-1) and 3 (0-4) (p = 0.212). Six weeks after surgery 0/11 and 1/11 patients suffered from evacuation difficulties (p = 1.0) and the median Vaizey-Wexner score was 1 (0-3) and 1 (0-2) (p = 0.360). CONCLUSIONS: Coloshield application in humans is feasible and safe. Slight benefits in rectal preparation by washout are found when Coloshield is used. Colon occlusion by Coloshield for transrectal NOTES should be evaluated within clinical studies. TRIAL REGISTRATION: Clinicaltrials.gov NCT02579330.
Authors: Philip C Müller; Jonas D Senft; Philip Gath; Daniel C Steinemann; Felix Nickel; Adrian T Billeter; Beat P Müller-Stich; Georg R Linke Journal: Surg Endosc Date: 2017-08-10 Impact factor: 4.584
Authors: D C Steinemann; P C Müller; P Probst; A-C Schwarz; M W Büchler; B P Müller-Stich; G R Linke Journal: Br J Surg Date: 2017-07 Impact factor: 6.939
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Authors: Alberto Arezzo; Carsten Zornig; Hamid Mofid; Karl-Hermann Fuchs; Wolfram Breithaupt; José Noguera; Georg Kaehler; Richard Magdeburg; Silvana Perretta; Bernard Dallemagne; Jacques Marescaux; Catalin Copaescu; Florin Graur; Andrei Szasz; Antonello Forgione; Raffaele Pugliese; Gerhard Buess; Hemanga K Bhattacharjee; Giuseppe Navarra; Mario Godina; Kirill Shishin; Mario Morino Journal: Surg Endosc Date: 2013-03-22 Impact factor: 4.584
Authors: Olga Miakicheva; Zachary Hamilton; Alp T Beksac; Sean W Berquist; Abd-Elrahman Hassan; Marc Holden; Ithaar H Derweesh Journal: World J Gastrointest Endosc Date: 2016-11-16