Alvimopan as a Rescue Treatment of Postoperative Ileus

NCT04405037 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20-321
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the cost effectiveness of Alvimopan as rescue therapy in patients undergoing colorectal or small bowel resection who develop POI, and its safety and effectiveness in reducing LOS and POI duration. This will be a prospective randomized control trial with a total of 58 patients, 29 in each group. Patients who undergo laparoscopic or open colorectal resection, small bowel resection, or ileostomy reversal with small bowel resection that subsequently develop postoperative ileus will be eligible for enrollment. If they meet inclusion/exclusion criteria, they will be randomized at the time of diagnosis of postoperative ileus to receive Alvimopan as rescue therapy or to receive conservative standard care. Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function.

Conditions

Ileus; Gastrointestinal Dysfunction

Outcome Measures

Primary Outcomes (1)

• Hospital Length of Stay

  Number of days from postoperative ileus diagnosis until discharge from hospital

  up to 30 days

Secondary Outcomes (3)

• Time to Return of Bowel Function

  up to 30 days

• Number of Participants With Re-operation

  within 30 days of surgery

• Number of Participants With Re-admissions

  up to 30 days

Study Arms (2)

Alvimopan Group

EXPERIMENTAL

Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function. All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.

Drug: Alvimopan

Control Group

NO INTERVENTION

Control patients will follow a standard ERAS pathway after surgery, including NPO status, IV fluid rehydration, and nasogastric decompression, early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.

Interventions

Alvimopan DRUG

Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery

Also known as: Entereg

Alvimopan Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects who have benign or malignant colonic or rectal disease that have undergone laparoscopic or open colorectal resection, small bowel resection or ileostomy reversal with small bowel resection and subsequently developed postoperative ileus, defined as:
• a. Patients with symptoms of bloating with or without nausea and vomiting, with absence of passage of flatus or stool who require either
• i. Return to NPO status after initial diet attempts
• ii. Undergo placement of a nasogastric tube
• b. Patients with absence of passage of flatus or stool who are either
• i. More than 5 days after open surgery without recovery of GI function
• ii. More than 3 days after laparoscopic surgery or ileostomy closure without recovery of GI function
• \. Subjects who are 18 years of age and older
• \. Subjects of either gender
• \. Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent.

You may not qualify if:

• \. Subjects who received Alvimopan preoperatively.
• \. Subjects that have taken therapeutic doses of opioids for more than 7 days immediately prior to surgery.
• \. Subjects with severe hepatic impairment.
• \. Subjects with end-stage renal disease.
• \. Subjects who are pregnant.
• \. Subjects who have undergone imaging suggesting a small bowel obstruction.
• \. Subjects with a medical condition that may interfere with the use of the study medication Alvimopan.
• \. Subjects who have a condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study

Sponsors & Collaborators

• Scott Steele: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (22)

• Story SK, Chamberlain RS. A comprehensive review of evidence-based strategies to prevent and treat postoperative ileus. Dig Surg. 2009;26(4):265-75. doi: 10.1159/000227765. Epub 2009 Jul 3.

  PMID: 19590205 BACKGROUND

• Bauer AJ, Boeckxstaens GE. Mechanisms of postoperative ileus. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:54-60. doi: 10.1111/j.1743-3150.2004.00558.x.

  PMID: 15357852 BACKGROUND

• Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.

  PMID: 11091234 BACKGROUND

• Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. doi: 10.1053/cgh.2003.50012.

  PMID: 15017498 BACKGROUND

• Luckey A, Livingston E, Tache Y. Mechanisms and treatment of postoperative ileus. Arch Surg. 2003 Feb;138(2):206-14. doi: 10.1001/archsurg.138.2.206.

  PMID: 12578422 BACKGROUND

• Delaney CP, Brady K, Woconish D, Parmar SP, Champagne BJ. Towards optimizing perioperative colorectal care: outcomes for 1,000 consecutive laparoscopic colon procedures using enhanced recovery pathways. Am J Surg. 2012 Mar;203(3):353-5; discussion 355-6. doi: 10.1016/j.amjsurg.2011.09.017. Epub 2012 Jan 20.

  PMID: 22264739 BACKGROUND

• Zhuang CL, Ye XZ, Zhang XD, Chen BC, Yu Z. Enhanced recovery after surgery programs versus traditional care for colorectal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2013 May;56(5):667-78. doi: 10.1097/DCR.0b013e3182812842.

  PMID: 23575408 BACKGROUND

• Delaney CP, Wolff BG, Viscusi ER, Senagore AJ, Fort JG, Du W, Techner L, Wallin B. Alvimopan, for postoperative ileus following bowel resection: a pooled analysis of phase III studies. Ann Surg. 2007 Mar;245(3):355-63. doi: 10.1097/01.sla.0000232538.72458.93.

  PMID: 17435541 BACKGROUND

• Delaney CP, Craver C, Gibbons MM, Rachfal AW, VandePol CJ, Cook SF, Poston SA, Calloway M, Techner L. Evaluation of clinical outcomes with alvimopan in clinical practice: a national matched-cohort study in patients undergoing bowel resection. Ann Surg. 2012 Apr;255(4):731-8. doi: 10.1097/SLA.0b013e31824a36cc.

  PMID: 22388106 BACKGROUND

• Senagore AJ, Bauer JJ, Du W, Techner L. Alvimopan accelerates gastrointestinal recovery after bowel resection regardless of age, gender, race, or concomitant medication use. Surgery. 2007 Oct;142(4):478-86. doi: 10.1016/j.surg.2007.07.004.

  PMID: 17950339 BACKGROUND

• Traut U, Brugger L, Kunz R, Pauli-Magnus C, Haug K, Bucher HC, Koller MT. Systemic prokinetic pharmacologic treatment for postoperative adynamic ileus following abdominal surgery in adults. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD004930. doi: 10.1002/14651858.CD004930.pub3.

  PMID: 18254064 BACKGROUND

• Zingg U, Miskovic D, Pasternak I, Meyer P, Hamel CT, Metzger U. Effect of bisacodyl on postoperative bowel motility in elective colorectal surgery: a prospective, randomized trial. Int J Colorectal Dis. 2008 Dec;23(12):1175-83. doi: 10.1007/s00384-008-0536-7. Epub 2008 Jul 30.

  PMID: 18665373 BACKGROUND

• Al-Mazrou AM, Baser O, Kiran RP. Alvimopan, Regardless of Ileus Risk, Significantly Impacts Ileus, Length of Stay, and Readmission After Intestinal Surgery. J Gastrointest Surg. 2018 Dec;22(12):2104-2116. doi: 10.1007/s11605-018-3846-2. Epub 2018 Jul 9.

  PMID: 29987738 BACKGROUND

• Jang J, Kwok B, Zhong H, Xia Y, Grucela A, Bernstein M, Remzi F, Hudesman D, Chen J, Axelrad J, Chang S. Alvimopan for the Prevention of Postoperative Ileus in Inflammatory Bowel Disease Patients. Dig Dis Sci. 2020 Apr;65(4):1164-1171. doi: 10.1007/s10620-019-05839-5. Epub 2019 Sep 14.

  PMID: 31522323 BACKGROUND

• Wen Y, Jabir MA, Keating M, Althans AR, Brady JT, Champagne BJ, Delaney CP, Steele SR. Alvimopan in the setting of colorectal resection with an ostomy: To use or not to use? Surg Endosc. 2017 Sep;31(9):3483-3488. doi: 10.1007/s00464-016-5373-0. Epub 2016 Dec 7.

  PMID: 27928668 BACKGROUND

• Steele SR, Brady JT, Cao Z, Baumer DL, Robinson SB, Yang HK, Delaney CP. Evaluation of Healthcare Use and Clinical Outcomes of Alvimopan in Patients Undergoing Bowel Resection: A Propensity Score-Matched Analysis. Dis Colon Rectum. 2018 Dec;61(12):1418-1425. doi: 10.1097/DCR.0000000000001181.

  PMID: 30312222 BACKGROUND

• Keller DS, Flores-Gonzalez JR, Ibarra S, Mahmood A, Haas EM. Is there value in alvimopan in minimally invasive colorectal surgery? Am J Surg. 2016 Nov;212(5):851-856. doi: 10.1016/j.amjsurg.2016.02.016. Epub 2016 May 10.

  PMID: 27262754 BACKGROUND

• Hyde LZ, Kiely JM, Al-Mazrou A, Zhang H, Lee-Kong S, Kiran RP. Alvimopan Significantly Reduces Length of Stay and Costs Following Colorectal Resection and Ostomy Reversal Even Within an Enhanced Recovery Protocol. Dis Colon Rectum. 2019 Jun;62(6):755-761. doi: 10.1097/DCR.0000000000001354.

  PMID: 30807457 BACKGROUND

• Asgeirsson T, El-Badawi KI, Mahmood A, Barletta J, Luchtefeld M, Senagore AJ. Postoperative ileus: it costs more than you expect. J Am Coll Surg. 2010 Feb;210(2):228-31. doi: 10.1016/j.jamcollsurg.2009.09.028. Epub 2009 Nov 18.

  PMID: 20113944 BACKGROUND

• Iyer S, Saunders WB, Stemkowski S. Economic burden of postoperative ileus associated with colectomy in the United States. J Manag Care Pharm. 2009 Jul-Aug;15(6):485-94. doi: 10.18553/jmcp.2009.15.6.485.

  PMID: 19610681 BACKGROUND

• Mao H, Milne TGE, O'Grady G, Vather R, Edlin R, Bissett I. Prolonged Postoperative Ileus Significantly Increases the Cost of Inpatient Stay for Patients Undergoing Elective Colorectal Surgery: Results of a Multivariate Analysis of Prospective Data at a Single Institution. Dis Colon Rectum. 2019 May;62(5):631-637. doi: 10.1097/DCR.0000000000001301.

  PMID: 30543534 BACKGROUND

• Tevis SE, Carchman EH, Foley EF, Harms BA, Heise CP, Kennedy GD. Postoperative Ileus--More than Just Prolonged Length of Stay? J Gastrointest Surg. 2015 Sep;19(9):1684-90. doi: 10.1007/s11605-015-2877-1. Epub 2015 Jun 24.

  PMID: 26105552 BACKGROUND

MeSH Terms

Conditions

Ileus

Interventions

alvimopan

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Scott Steele
• Organization: Cleveland Clinic Foundation

steeles3@ccf.org

216-444-4715

Study Officials

• Conor Delaney, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: August 1, 2020
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: August 20, 2025
• Results First Posted: August 20, 2025

Record last verified: 2025-08

Locations

US (1)