Fecal diverting device for the substitution of defunctioning stoma: preliminary clinical study

Jae Hwang Kim, Sohyun Kim, Sang Hun Jung, Jae Hwang Kim, Sohyun Kim, Sang Hun Jung

Abstract

Background: A 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.

Methods: A 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.

Results: Thirty-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.

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.

Keywords: Anastomotic leakage; Fecal diversion; Fecal diverting device; Ileostomy; Low anterior resection; Stoma.

Conflict of interest statement

Jae Hwang Kim, Sohyun Kim, and Sang Hun Jung have no conflicts of interest or financial ties to disclose.

Figures

Fig. 1
Fig. 1
Fecal diverting device (FDD) with inner and outer balloon inflated. The white arrow indicates the channel for irrigation water infusion. The catheter complex tip consists of a blue tip for outer balloon, red tip for inner balloon control, and water infusion port. The catheter complex tip will be fixed to the low abdomen or upper thigh with an adhesive plaster
Fig. 2
Fig. 2
The FDD was attached in the colon by the extraluminal absorbable PGLA mesh band (BAND) indicated by a black arrow
Fig. 3
Fig. 3
The role of the outer and inner balloons of the fecal diverting device
Fig. 4
Fig. 4
An automatic tension measuring instrument (ATMI, JSR medical Inc, Daegu, Korea). The narrow part of the transparent band breaks automatically if tension reaches a certain point while it is wrapped around the colon. This point indicates a safe compression pressure of the band around the bowel
Fig. 5
Fig. 5
Schematic drawing of fecal diverting device in the colon
Fig. 6
Fig. 6
Study flow chart

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