Using Alvimopan to treat postoperative ileus after bowel surgery

A Prospective Randomized Control Trial of The Effectiveness of Alvimopan as a Rescue Treatment of Postoperative Ileus Following Colorectal Surgery

This study is testing if a medication called Alvimopan can help people who have trouble with their bowels after bowel surgery recover faster and leave the hospital sooner.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT04405037 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and cost efficiency of Alvimopan as a rescue therapy for patients who develop postoperative ileus (POI) following colorectal or small bowel surgeries. The study involves a prospective randomized control design with 58 participants, who will be divided into two groups: one receiving Alvimopan and the other receiving standard care. The primary goal is to determine if Alvimopan can reduce the duration of POI and the length of hospital stay. Patients will be monitored for bowel function recovery after receiving a maximum of three doses of Alvimopan.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have undergone specific bowel surgeries and subsequently developed postoperative ileus.

Not a fit: Patients who do not develop postoperative ileus or those with contraindications to Alvimopan may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce recovery time and hospital stays for patients experiencing postoperative ileus.

How similar studies have performed: Previous studies have shown promising results with Alvimopan in similar contexts, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* 1. 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

2. Subjects who are 18 years of age and older

3. Subjects of either gender

4. Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent.

Exclusion Criteria:

* 1. Subjects who received Alvimopan preoperatively.

  2. Subjects that have taken therapeutic doses of opioids for more than 7 days immediately prior to surgery.

  3. Subjects with severe hepatic impairment.

  4. Subjects with end-stage renal disease.

  5. Subjects who are pregnant.

  6. Subjects who have undergone imaging suggesting a small bowel obstruction.

  7. Subjects with a medical condition that may interfere with the use of the study medication Alvimopan.

  8. Subjects who have a condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Conor Delaney, MD, PhD — The Cleveland Clinic
• Study coordinator: Conor Delaney, MD, PhD

Conditions Ileus; Gastrointestinal Dysfunction