Clinical Safety and Effectiveness of COLO-BT™, an Intraluminal Fecal Diverting Device, as an Alternative to...

ObjectiveThis study aimed to evaluate the safety and effectiveness of an intraluminal fecal diverting device (FDD), COLO-BT™ as an alternative to defunctioning ileostomy in patients who declined stoma formation following proctectomy.MethodsWe retrospectively reviewed the medical records of patients who underwent proctectomy followed by placement of an intraluminal FDD (COLO-BT™) as a temporary substitute for ileostomy at a single tertiary care center between September 2017 and September 2021. Safety was assessed based on postoperative and anastomotic complications, as well as endoscopic findings of colonic changes at the FDD fixation site. Effectiveness was evaluated by the rate of permanent stoma formation.ResultsAmong 91 patients, 8 (8.8%) required surgical re-intervention. Of these, five patients experienced anastomotic complications necessitating stoma formation: rectovaginal fistula (n = 2), delayed anastomotic leakage (n = 2), and rectourethral fistula (n = 1). One patient developed severe ileus requiring surgery, which also resulted in stoma formation. Overall, six patients (6.6%) underwent permanent stoma formation during a mean follow-up period of 24 months. Endoscopic follow-up identified colonic luminal deformities in 15 patients (16.5%), most of which were asymptomatic mucosal edema or erosion (n = 12). Three patients (3.3%) had non-symptomatic ulcers at the FDD fixation site. All luminal deformities had resolved on follow-up sigmoidoscopy performed 1 year later.ConclusionThe intraluminal FDD (COLO-BT™) may offer a feasible alternative to defunctioning ileostomy following proctectomy in selected patients, with acceptable rates of postoperative complications and permanent stoma formation. Further studies are needed to confirm long-term safety and efficacy.