Long-term fecal diverting device for the prevention of sepsis in case of colorectal anastomotic leakage: an animal experiment

Abstract

BackgroundA new fecal diverting device (FDD) was fabricated for fecal diversion from the proximal colon above the anastomosis to outside the anus for protecting the rectal anastomosis. The aim of the study is to evaluate the safety and effectiveness of the FDD.MethodsAfter a pilot study, a prospective observational trial was performed in 34 mongrel dogs. The experiment comprised of segmental resection and anastomosis of the colon, fixation of the FDD, and observation for 3 weeks (n = 15) and more than 3 weeks (n = 19) without initiation of parenteral nutrition.ResultsFour cases of perioperative death unrelated to the FDD were excluded. Twenty-six (87 %) of the 30 dogs survived. Sixteen (53 %) dogs were able to retain the FDD for more than 3 weeks until 82 days. The autopsy findings revealed that four (15 %) dogs showed colonic wall erosions and mucosal scarring respectively at the band fixation area without evidence of serious septic complications. The surviving dogs retained the FDD for more than 6 days. Mortality occurred in four of the five dogs that expelled the FDD within three postoperative days. A closed abscess cavity as the evidence of anastomotic leakage was noted in seven (23 %) of the surviving dogs.ConclusionsThe newly designed fecal diverting device can be retained for more than 3 weeks until 82 days without any serious complications. The FDD may prevent sepsis in case of anastomotic leakage if it is retained for more than 6 days.

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

“…1). It showed a successful fecal diversion and long maintenance duration of up to 82 days in an animal study [16]. Thus, the FDD could prevent development of serious septicemia in conditions of AL.…”

“…Even though erosion developed at a rate of 10%, the absence of treatment or conservative treatment was enough to solve the problem. In the previous animal study, there was a 15% erosion rate; however, there were no serious conditions that required reintervention [16]. Nevertheless, it would be preferable if no erosion developed, even if it did not require a surgical reintervention.…”

“…We were able to estimate the safe pressure range from the previous animal study [16] and could make a device ATMI. This worked well and resulted in no loss of device and no acute intra-abdominal surgical complication.…”

“…The FDD is a silicone tube device [16], designed for the protection from fecal contamination of an anastomotic wound using fecal diversion. The FDD is composed of 2 parts, a solid tubular head portion and a thin tubular tail portion.…”

Ileostomy versus fecal diversion device to protect anastomosis after rectal surgery: a randomized clinical trial

“…Here, we tested a device to protect anastomosis and replace ileostomy. Based on previous animal experiments, we developed a fecal diversion device (FDD) with an absorbable mesh band for fixation [8]. Thus, this study aimed to identify the clinical safety and efficacy of the FDD.…”