A Randomized Clinical Trial comparing Immediate to MOdified DElayed coloanal anastomosis after total mesorectal excision: the IMODE trial protocol

Abstract

Abstract Purpose Immediate coloanal anastomosis (ICA) remains the standard technique for restoring the digestive tract after proctectomy for low rectal cancer. Often, it requires a temporary diversion stoma, thus increasing the risk of complications. Recent data have shown a great potential of the delayed coloanal anastomosis (DCA) both in decreasing anastomosis morbidity and in avoiding ileostomy to the patients. More recently, a modified delayed coloanal anastomosis (mDCA) has been described and seems to have promising results. This study aims to determine whether mDCA is non-inferior to ICA. Methods The IMODE trial is a randomized, controlled, non-inferiority trial designed to enroll 70 adults with mid or low rectal cancer. Participants are randomized to ICA or mDCA. The primary endpoint is the anastomotic fistulas (AF) rate at 6 months. Conclusions The mDCA can constitute an interesting modality to restore the digestive tract following proctectomy for mid and low rectal cancer; this by decreasing the morbidity of the coloanal anastomosis on the one hand and by avoiding ileostomy on the other hand. Trial registration PACTR202209500145137, September 9th, 2022 (retrospectively registered).