Alvimopan as Rescue in Post op Ileus

NCT02742181 | Terminated Phase 3 Results DMC

• 1 other identifier: 10-15-28
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective randomized control trial with a total of 142 patients. 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 Entereg as rescue therapy or to receive conservative standard care. Patients randomized to the Entereg group will be given 12mg of Entereg two times daily from the time of randomization until the return of bowel function or 5 days. Both groups will be treated with conservative standard care, including bowel rest, reduction in oral diet, and placement of nasogastric tube as clinically indicated. 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. Primary outcome will be hospital length of stay. Secondary outcomes will include time to return of bowel function, 30-day morbidity/mortality, complications, reoperation and readmission. Total number of patients: 142 Patients in each study group: 71

Conditions

Colorectal Surgery; Ileus

Outcome Measures

Primary Outcomes (1)

• Hospital Length of Stay

  Date of surgery until discharge

  up to 30 days

Secondary Outcomes (4)

• Time to Return of Bowel Function

  30 days

• Complications

  30 days

• Number of Reoperations

  30 days

• Number of Readmissions

  30 days

Study Arms (2)

Alvimopan group

EXPERIMENTAL

In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.

Drug: Alvimopan

Control Group

OTHER

Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression.

Other: Control Group

Interventions

Alvimopan DRUG

Subjects diagnosed with a post operative ileus after surgery will be given alvimopan

Also known as: Entereg

Alvimopan group

Control Group OTHER

Standard postoperative care

Control 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:
• Return to NPO status after initial diet attempts, or
• Placement of nasogastric tube
• 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 Entereg 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 were diagnosed with a complete small bowel obstruction preoperatively.
• Subjects with a medical condition that may interfere with the use of the study medication Entereg.
• 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

• Sharon Stein: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (12)

• 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

MeSH Terms

Conditions

Ileus

Interventions

alvimopan; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Sharon Stein
• Organization: University Hospitals Cleveland Medical Center

Sharon.Stein@UHhospitals.org

(216)844-2873

Study Officials

• Sharon Stein, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Surgeon, Associate Professor of Surgery

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 18, 2016
• Study Start: December 2, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 18, 2022
• Results First Posted: November 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)