The ILEOSTIM trial: A multicentre randomised controlled trial evaluating the impact of efferent loop stimulation prior to ileostomy reversal on postoperative ileus.

Abstract

Strategies to optimise bowel function before stoma reversal surgery (SRS) are needed to improve postoperative outcomes. Efferent bowel stimulation (EBS) prior to stoma closure has been proposed as a potential strategy to reduce postoperative ileus (POI) incidence and improve the patient's postoperative course. A multicentre randomised controlled trial was designed to evaluate the effectiveness of pre-SRS EBS in reducing POI incidence. Patients scheduled for elective SRS were randomised 1:1 to either an intervention group, receiving daily EBS with saline and a nutritional thickener for 2 weeks preoperatively, or a control group, undergoing SRS without stimulation. The primary endpoint was POI incidence. Secondary outcomes included the time to oral diet tolerance, passage of first flatus/stool, surgery-related comorbidities, length of hospital stay and incidence of Low Anterior Resection Syndrome (LARS) (NCT05302557-31/03/2022). From June 2021 to April 2023, 175 patients were enrolled from 18 hospitals in Spain, 78 (44.5%) and 97 (55.4%) of whom were allocated to the intervention and control groups, respectively. We found that EBS was not significantly associated with a decrease in POI incidence (7.6% vs. 16.4%, p = 0.088). No significant differences in the median hospital stay (p = 0.545) or LARS at discharge (p = 0.087) were observed between the two groups. The EBS group showed fewer but more severe complications (p = 0.015). Preoperative EBS is a feasible and reproducible intervention that may represent a potential strategy to reduce POI following SRS.