Bowel stimulation before loop ileostomy closure to reduce postoperative ileus: a multicenter, single-blinded, randomized controlled trial

Abstract

Abstract Introduction The objective of this study was to evaluate the impact of preoperative bowel stimulation on the development of postoperative ileus (POI) after loop ileostomy closure. Methods This was a multicenter, randomized controlled trial (NCT025596350) including adult (≥ 18 years old) patients who underwent elective loop ileostomy closure at 7 participating hospitals. Participants were randomly assigned (1:1) using a centralized computer-generated sequence with block randomization to either preoperative bowel stimulation or no stimulation (control group). Bowel stimulation consisted of 10 outpatient sessions within the 3 weeks prior to ileostomy closure and was performed by trained Enterostomal Therapy nurses. The primary outcome was POI, defined as an intolerance to oral food in the absence of clinical or radiological signs of obstruction, on or after postoperative day 3, that either (a) required nasogastric tube insertion; or (b) was associated with two of the following: nausea/vomiting, abdominal distension, or the absence of flatus. Results Between January 2017 and November 2020, 101 patients were randomized, and 5 patients never underwent ileostomy closure; thus, 96 patients (47 stimulated vs. 49 control) were analyzed according to a modified intention-to-treat protocol. Baseline characteristics were well balanced in both groups. The incidence of POI was lower among patients randomized to stimulation (6.4% vs. 24.5%, p = 0.034; unadjusted RR: 0.26, 95% CI 0.078–0.87). Stimulated patients also had earlier median time to first flatus (2.0 days (1.0–2.0) vs. 2.0 days (2.0–3.0), p = 0.025), were more likely to pass flatus on postoperative day 1 (46.8% vs. 22.4%, p = 0.022), and had a shorter median postoperative hospital stay (3.0 days (2.0–3.5) vs. 4.0 days (2.0–6.0), p = 0.003). Conclusions Preoperative bowel stimulation via the efferent limb of the ileostomy reduced POI after elective loop ileostomy closure.