Crohn’s disease is a common indication for bowel resection (BR), and the prevalence of surgery (strictureplasty or BR) in this setting ranges from 38% to 96%. Postoperative ileus (POI), a temporary impairment of GI function, occurs after abdominal surgery. Alvimopan, a novel, peripherally acting, mu-opioid receptor antagonist under investigation for the management of POI, accelerated GI recovery in patients undergoing laparotomy for BR or total abdominal hysterectomy in 3 multicenter phase III trials. Pooled data from these trials were analyzed for patients with and without CD who received SBR. Trials enrolled patients ≥18 years old who were scheduled for postoperative opioid IV patient-controlled analgesia. Alvimopan (6 or 12 mg) or placebo was administered 0.5 to 5 hours before surgery and twice daily starting postoperative day (POD) 1 until hospital discharge for ≤ 7 PODs. Cox proportional hazard ratios were used to analyze treatment effects on time to events and to provide an estimate (in hours) of treatment effect. The primary endpoint was GI-3 recovery (time to first flatus or bowel movement [BM] and toleration of solid food). Secondary endpoints included time to first BM and time to hospital discharge order written. Of the patients who participated in the phase III alvimopan trials, 47 patients with CD and 54 patients without CD underwent SBR. Results are reported in Table 1. Although the number of patients in this analysis was small, patients who received alvimopan (regardless of their CD diagnosis) had reduced time to GI recovery and discharge compared with placebo. Moreover, efficacy was comparable for patients with and without CD.
Table 1. Time to Recovery in Patients Undergoing SBR With and Without CD, MITT Population

SBR = Small bowel resection; CD = Crohn’s disease; MITT = Modified intent to treat; GI-3 = Time to first flatus or BM and toleration of solid food; HR = Hazard ratio; CI = Confidence interval; BM = Bowel movement; DCO = Discharge order.