Abstract
BackgroundTransrectal 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.MethodsTwenty-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.ResultsBBPS 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).ConclusionsColoshield 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 registrationClinicaltrials.gov NCT02579330
Highlights
Transrectal Natural Orifice Transluminal Endoscopic Surgery is currently limited by the inherent risk of surgical site infection due to peritoneal contamination after rectotomy
Even after mechanical bowel preparation positive abdominal swabs were obtained in left colonic resections with transrectal natural orifice specimen extraction in up to 100% of patients [10, 11]
While there was no difference in the gender distribution among the groups, patients in the control group were younger than patients in the Coloshield group
Summary
This was a prospective, randomized clinical, single-center trial comparing the effectiveness and safety of a rectal washout with and without the use of Coloshield in a group of patients undergoing surgery for fistula-in-ano, or hemorrhoids. Data from the enrolled patients were prospectively included in an institutional study registry which was based on case reporting forms and an excel spreadsheet This included demographic data such as age, sex, indication for surgery, numeric rating scale (NRS) for pain before surgery, the anorectal function before surgery, as well as clinical data such as duration of surgery, NRS for pain 4 h, 24 h, 48 h, and 72 h after surgery. In the rectoscopy performed at the end of surgery in one case of the Coloshield group a minor bleeding of the rectal mucosa approximately 3 cm above the dentate line was observed and was self-limiting. It was most likely caused by the anal spreader. Importantly, there was no difference in bowel function and fecal continence six weeks after surgery between the Coloshield and control group (Table 2)
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