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Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC — ILEUS  

Ileus Clinical Trial

Official title:
The ILEUS Study: A Phase 2 Randomized Controlled Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Clinical Trial Summary

The purpose of this study is to investigate the ability of alvimopan to reduce the time to return of bowel function in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Half of the participants will receive alvimopan or and half will receive placebo immediately before and for up to seven days after surgery.

Clinical Trial Description

Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a surgical procedure to treat cancer that has spread to the lining of the abdominal cavity (peritoneal metastases). It is associated with a prolonged time for return of bowel function after surgery. Alvimopan is a drug used to speed up the time for return of bowel function after surgery. It works by blocking the opioid receptors in the gastrointestinal tract, which normally slow down bowel function in patients receiving postoperative opioid pain medication. It has not previously been tested in patients undergoing CRS/HIPEC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03352414
Study type Interventional
Source University of California, San Diego
Contact
Status Terminated
Phase Phase 2
Start date March 8, 2018
Completion date April 28, 2020
View Details
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