Background: Surgical management of peritoneal metastases with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) is associated with prolonged length of stay and time to return of bowel function. Alvimopan is a peripherally acting opioid antagonist that reduces postoperative ileus. We sought to determine the efficacy of alvimopan on return of bowel function in patients undergoing CRS-HIPEC.
Methods: A double-blind, randomized, placebo-controlled, single-institution, IRB-approved trial was conducted in patients undergoing CRS-HIPEC from March 2018 to April 2020. Patients received alvimopan or placebo preoperatively and twice daily postoperatively for 7 days. The primary endpoint (GI-2) was the time of tolerance of solid food and first bowel movement (BM). Secondary endpoints were the proportion of patients with prolonged ileus, time to first flatus, first BM, tolerance of solid food, discharge, and adverse events (AEs).
Results: Sixty-two patients met eligibility criteria and received placebo (n = 32) or alvimopan (n = 30), and were included in the analysis. The median time to GI-2 was 152 hours (95% CI 134, 204) in the placebo arm versus 117 hours (95% CI 102, 158) in the alvimopan arm (p = 0.04). The time to BM was 89 hours (95% CI 71, 114) in the placebo arm vs 67 hours (95% CI 62, 89) in the alvimopan arm (p = 0.02). There were no significant differences in AE rates, proportion of patients with prolonged ileus, or other secondary endpoints.
Conclusion: Perioperative alvimopan was well tolerated and accelerated bowel function recovery in patients undergoing CRS-HIPEC.
Trial registration: ClinicalTrials.gov NCT03352414.
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