Rectal stimulation with prebiotics and probiotics before ileostomy reversal: a study protocol for a randomized controlled trial

Abstract

Background Ileostomy closure is associated with a high rate of postoperative morbidity, and adynamic ileus is the most common complication, with an incidence of up to 32%. This complication is associated with delayed initiation of oral diet intake, abdominal distention, prolonged hospital stay, and more significant patient discomfort. The present study aims to evaluate the rectal stimulus with prebiotics and probiotics before ileostomy reversal. Methods This is a protocol study for an open-label randomized controlled clinical trial. Ethical approval was received (CAAE: 56551722.6.0000.0071). The following criteria will be used for inclusion: adult patients with rectal cancer stages cT3/4Nx or cTxN+ that underwent loop protection ileostomy, patients treated with neoadjuvant chemoradiotherapy, and patients who underwent laparoscopic or robotic total mesorectal excision. Patients will be randomized to one of two groups. The intervention group (with rectal stimulus): the patients will apply 500 ml of saline solution with 6 g of Simbioflora® rectally, once a day, for 15 days before ileostomy closure. The control group (without rectal stimulation): the patients will close the ileostomy with no previous rectal stimulus. The primary outcomes will be the adynamic ileus (need for postoperative nasogastric tube insertion; nausea/vomiting; or intolerance to oral feedings within the first 72 h) and intestinal transit (time to first evacuation/flatus). Results The patient’s enrollment starts in January 2023. We expect to finish in July 2025. Discussion The findings of this randomized clinical study may have important implications for managing patients undergoing ileostomy reversal. Trial registration This study is registered in the Brazilian Trial Registry (ReBEC) under RBR-366n64w. Registration date: 19/07/2022