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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
UCSD Moores Cancer Center
La Jolla, California, United States
Time to Return of Upper and Lower GI Function
The later of the time from surgery that the participant first tolerates solid food and the time that the participant first passes a bowel movement.
Time frame: from surgery to discharge (generally no longer than two weeks)
Prolonged Ileus
The proportion of patients who do not pass flatus or bowel movement greater than 7 days from the time of surgery.
Time frame: from surgery to discharge (generally no longer than two weeks)
Time to Return of Bowel Function Components
The time from surgery until: * The time to first flatus * The time to first bowel movement * The time to tolerance of solid food
Time frame: from surgery to discharge (generally no longer than two weeks)
Time to Discharge
The time from surgery until discharge order written.
Time frame: from surgery to discharge (generally no longer than two weeks)
Serious Adverse Events
The number and proportion of serious adverse events.
Time frame: up to 30 days from surgery
Subgroup Analyses
All primary and secondary outcomes will be measured in the following subgroups: * 0 vs. 1 or greater bowel anastomoses * 0 vs. 1 or greater visceral resections * high vs. low amount of postoperative opioid use * epidural vs. no epidural
Time frame: up to 30 days from surgery
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