Randomized clinical trial on the use of a colon-occlusion device to assist rectal washout
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and Other Interventional Techniques
Randomized clinical trial on the use of a colon‑occlusion device to assist rectal washout Carolin Cordewener1 · Manuel Zürcher2 · Philip C. Müller3 · Beat P. Müller‑Stich4 · Andreas Zerz5 · Georg R. Linke2 · Daniel C. Steinemann1,6 Received: 26 May 2020 / Accepted: 14 September 2020 © The Author(s) 2020
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 Keywords Colon occlusion · Natural orifice transluminal endoscopic surgery · Transrectal · Peritoneal contamination · Proctology In procedures that involve a rectotomy such as transanal endoscopic microsurgery (TEM) or transrectal natural orifice transluminal endoscopic surgery (NOTES) there is an inherent risk of pelvic or abdominal sepsis and of leakage from insufficiency of a rectotomy closure. In TEM suture line dehiscence after TEM is described to be as frequent as 23% in chemoradiation-naïve rectum [1]. However, dehiscence in the extraperitoneal part of the rectum does not necessarily translate into pelvic sepsis considering the ability
Carolin Cordewener and Manuel Zürcher have equally contributed to the manuscript as first co-author. * Daniel C. Steinemann [email protected] Extended author information available on the last page of the article
of the well vascularized mesorectal fat to serve as a matrix for rectal wall regrowth. In a serie
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