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Session: Abstract Session: Quality and Cost w/Basic and Translational Science

P407 - A Prospective Randomized Controlled Trial of the Effectiveness of Alvimopan as a Rescue Treatment of Postoperative Ileus Following Colorectal Surgery

Tuesday, May 13, 2025

9:22 AM – 9:28 AM PT

Location: Ballroom 6B, Upper Level

Abstract Podium Presenter(s)

Oscar Hernandez Dominguez, MD MBA (he/him/his)

Resident
Cleveland Clinic Foundation
Cleveland Clinic
Cleveland Heights, OH, United States

All of the relevant financial relationships listed below have been mitigated.
This individual has no financial relationships with ineligible companies.

Author(s)

MM

Moustafa Moussally, MD

Resident
Cleveland Clinic
Cleveland, Ohio, United States

All of the relevant financial relationships listed below have been mitigated.
This individual has no financial relationships with ineligible companies.
HS

Himani Sancheti, MS

Statistician
Cleveland Clinic Foundation
Cleveland, Ohio, United States

Disclosure information not submitted.
David R. Rosen, MD

Colorectal Surgeon
Cleveland Clinic
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, United States

All of the relevant financial relationships listed below have been mitigated.
Applied Medical: Teaching (Ongoing); Medtronic: Teaching (Terminated, June 2, 2024)
Hermann Kessler, MD, PhD, Professor of Surgery (he/him/his)

Staff
Cleveland Clinic Foundation-Main Campus
Cleveland, OH, United States

All of the relevant financial relationships listed below have been mitigated.
This individual has no financial relationships with ineligible companies.
Jeremy M. Lipman, MD (he/him/his)

Director of Graduate Medical Education
Cleveland Clinic Foundation
Cleveland, Ohio, United States

All of the relevant financial relationships listed below have been mitigated.
This individual has no financial relationships with ineligible companies.
AK

Arielle E. Kanters, MD, MS

Colorectal Surgeoin
Cleveland Clinic
Cleveland, Ohio, United States

Disclosure information not submitted.
Anna R. Spivak, DO (she/her/hers)

Assistant Professor
Cleveland Clinic Foundation
Cleveland Clinic Foundation
Cleveland, Ohio, United States

All of the relevant financial relationships listed below have been mitigated.
Medtronic: Advisor or Review Panel Member (Ongoing)
EG

Emre Gorgun, MD, MBA

Vice Chair, Department of Colorectal Surgery
Cleveland Clinic Foundation-Main Campus
Cleveland, Ohio, United States

All of the relevant financial relationships listed below have been mitigated.
This individual has no relevant relationships with ineligible companies.
Stefan D. Holubar, MD, MS, FACS, FASCRS

Director of Research
Cleveland Clinic
Cleveland, Ohio, United States

All of the relevant financial relationships listed below have been mitigated.
This individual has no relevant relationships with ineligible companies.
David Liska, MD

Associate Professor, Chair
Department of Colorectal Surgery, Cleveland Clinic
Cleveland Clinic, Cleveland, Ohio
Cleveland, Ohio, United States

Disclosure information not submitted.

Senior Author(s)

Scott R. Steele, MD, MBA

President, Cleveland Clinic, Main Campus Submarket and Rupert B. Turnbull M.D., Endowed Chair in Colorectal Surgery
Cleveland Clinic
Cleveland, OH, United States

All of the relevant financial relationships listed below have been mitigated.
This individual has no financial relationships with ineligible companies.

Submitting Author(s)

Oscar Hernandez Dominguez, MD MBA (he/him/his)

Resident
Cleveland Clinic Foundation
Cleveland Clinic
Cleveland Heights, OH, United States

All of the relevant financial relationships listed below have been mitigated.
This individual has no financial relationships with ineligible companies.

All of the relevant financial relationships listed below have been mitigated.

Oscar Hernandez Dominguez, MD MBA: This individual has no financial relationships with ineligible companies.

Moustafa Moussally, MD: This individual has no financial relationships with ineligible companies.

David R. Rosen, MD: Applied Medical: Teaching (Ongoing); Medtronic: Teaching (Terminated, June 2, 2024)

Hermann Kessler, MD, PhD, Professor of Surgery: This individual has no financial relationships with ineligible companies.

Jeremy M. Lipman, MD: This individual has no financial relationships with ineligible companies.

Anna R. Spivak, DO: Medtronic: Advisor or Review Panel Member (Ongoing)

Emre Gorgun, MD, MBA: This individual has no relevant relationships with ineligible companies.

Stefan D. Holubar, MD, MS, FACS, FASCRS: This individual has no relevant relationships with ineligible companies.

Scott R. Steele, MD, MBA: This individual has no financial relationships with ineligible companies.

Image or Table (Do Not add text here):

Purpose/Background: Postoperative ileus (POI) is a significant cause of delayed recovery in up to 25% of patients undergoing colorectal surgery. POI is associated with increased morbidity, hospital length of stay (LOS), reoperation rates, and readmission rates. Alvimopan, a selective mu-opioid receptor antagonist, has demonstrated efficacy in reducing the time to return of bowel function, LOS, and the cost of abdominal bowel resection surgery. Alvimopan is currently administered prophylactically to prevent the development of POI. The high cost of alvimopan is a significant concern, and prophylactic administration to all patients undergoing colorectal resection may not be economically viable, as not all patients develop POI. We conducted a study to evaluate the efficacy of alvimopan as a POI rescue therapy. We hypothesized that alvimopan can be used as a rescue therapy for POI in patients undergoing colorectal and small bowel resection surgery to shorten the length of hospital stay.

Methods/Interventions: This was a single-center, prospective, randomized controlled trial. Patients who underwent minimally invasive or open intestinal resection for colorectal disease and subsequently developed POI were eligible. Patients were randomized at the time of POI diagnosis to receive either alvimopan or standard care. POI was defined as symptoms of bloating, nausea, and vomiting requiring either return to NPO status after initial diet attempts, placement of an NGT, or absence of bowel function more than five days after open surgery or more than three days after MIS or ileostomy closure. Standard postoperative care adhered to the enhanced recovery program (ERP), which incorporated early feeding, ambulation, and opioid-minimizing measures. The enrollment goal was 29 patients per group to achieve 80% power to detect a decrease of at least 35% in LOS after POI diagnosis. Patients were administered a maximum of three doses of 12 mg alvimopan orally, 12 hours apart. The primary outcome measure was hospital length of stay (LOS) after POI diagnosis. Secondary outcome measures included time to return of bowel function, time to tolerate a soft gastrointestinal diet, 30-day postoperative complications, reoperation rates, and readmission rates.

Results/Outcomes: A total of 65 patients were included in the alvimopan (n=33) and standard care (n=32) groups. Patients in the alvimopan and standard care groups had similar characteristics (Table 1). The two study groups did not exhibit a significant difference in the primary outcome of hospital LOS (p=0.12) (Table 2). Time to return of bowel function was shorter in the alvimopan group compared to the standard of care group (1.12 vs 1.94 days, p=0.01). The time required to advance to GI soft diet did not differ between groups (p=0.12). Postoperative complications (p=0.4), reoperation rates (p=0.5), and readmission rates (p=0.6) did not differ between the groups.

Conclusion/Discussion: These findings indicate that Alvimopan as a rescue therapy may be efficacious in facilitating the restoration of bowel function in patients with POI, although it did not significantly affect the overall hospital LOS.