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

ABSTRACT

PURPOSE: 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. METHODS: 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 2 years after undergoing the FDD procedure or defunctioning stoma creation. RESULTS: 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 > 24 months 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). CONCLUSIONS: The FDD procedure is a feasible substitute for a defunctioning stoma after proctectomy. Multicenter large-scaled clinical studies are required to validate our results.