Abstract

BackgroundA novel fecal diverting device (FDD) made for the prevention of sepsis resulting from anastomotic leakage (AL) was tested successfully in an animal study. This study was undertaken to evaluate the clinical safety and effectiveness of the FDD.MethodsA prospective observation trial was implemented in a tertiary referral university hospital. The study enrolled patients who needed a defunctioning stoma to preserve low-lying rectal anastomosis. The FDD was fixed to the proximal colon 15 cm from the anastomosis and scheduled to divert feces for 3 weeks. The duration could be extended for more than 3 weeks if AL was noted. Postoperative evaluations of AL were performed by obtaining a computed tomography (CT) scan after 1 week and a contrast study after 3 weeks. The outcomes were FDD-related complications, and the capacity of the FDD to preserve the anastomosis. The median follow-up period was 10 (range 5–40) months.ResultsThirty-one patients, including 5 benign cases, were evaluated. There was no case of stoma conversion or surgical re-intervention. Evidence of AL was identified in 10 (32%) patients using the CT scan at 1 week after surgery. However, in the contrast study at 3 weeks after surgery, only 5 cases of AL sinus were noted. Conservative treatments including 1–3 weeks prolongation of FDD maintenance were enough to preserve the anastomosis. There were 3 cases of partial colonic wall erosions at the FDD attachment area. All of these patients showed improvement with conservative treatment. The limitations were that the study was performed in a single institute and without a control group.ConclusionsThe FDD showed a sufficient capacity of fecal diversion and maintenance duration that prevented aggravation of sepsis in the case of AL without significant complications.

Highlights

  • A novel fecal diverting device (FDD) made for the prevention of sepsis resulting from anastomotic leakage (AL) was tested successfully in an animal study

  • The definition of AL in this study was a defect in the intestinal wall integrity at the colorectal or coloanal anastomotic site, which led to communication between the intraluminal and extraluminal compartments

  • A pelvic abscess close to the anastomosis is considered as AL [17]

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Summary

Introduction

A novel fecal diverting device (FDD) made for the prevention of sepsis resulting from anastomotic leakage (AL) was tested successfully in an animal study. The study enrolled patients who needed a defunctioning stoma to preserve low-lying rectal anastomosis. The FDD was fixed to the proximal colon 15 cm from the anastomosis and scheduled to divert feces for 3 weeks. Results Thirty-one patients, including 5 benign cases, were evaluated. In the contrast study at 3 weeks after surgery, only 5 cases of AL sinus were noted. Conservative treatments including 1–3 weeks prolongation of FDD maintenance were enough to preserve the anastomosis. There were 3 cases of partial colonic wall erosions at the FDD attachment area. All of these patients showed improvement with conservative treatment. Conclusions The FDD showed a sufficient capacity of fecal diversion and maintenance duration that prevented aggravation of sepsis in the case of AL without significant complications

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