Two-year follow-up results of the use of a fecal diverting device as a substitute for a defunctioning stoma.

Abstract

Our previously published clinical studies described the short-term outcomes of a newly developed intraluminal fecal diverting device (FDD). FDD was a safe and effective substitute for a defunctioning stoma. However, the long-term efficacy and safety of this device remain unknown. We investigated the long-term outcomes of the use of the FDD as a substitute for a defunctioning stoma. We examined the medical records of patients who participated in our two previous FDD clinical studies. The main outcome was the number of patients with bowel continuity for 2years after undergoing the FDD procedure or defunctioning stoma creation. Between May 2015 and July 2018, 85 patients were screened for inclusion in this study. Of those, 27 patients underwent a defunctioning ileostomy after proctectomy. The remaining 58 underwent the FDD procedure after proctectomy. Seventy-two patients (ileostomy group, n = 22; FDD group, n = 50) with a follow-up duration > 24months were included in this analysis. The mean duration of fecal diversion was significantly shorter (p < 0.001) in the FDD group (3.1 [1.6-6.1] weeks) than in the ileostomy group (16.7 [10.0-31.6] weeks). However, the rate of permanent stoma creation was not statistically different between the two groups (ileostomy and FDD groups, 13.6% [3/22] and 10.0% [5/50], respectively; p = 0.693). The FDD procedure is a feasible substitute for a defunctioning stoma after proctectomy. Multicenter large-scaled clinical studies are required to validate our results.