NCT02004652

Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery

A Randomized, Controlled, Double-blind Efficacy and Tolerability Study Of Prucalopride For The Treatment Of Postoperative Ileus In Patients Undergoing Gastrointestinal Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect and safety of prucalopride on recovery of gastrointestinal function in patient undergoing major gastrointestinal surgery. The investigators hypothesize that patients who take prucalopride after major gastrointestinal surgery will have shorter duration of postoperative ileus.

Detailed description

Postoperative ileus (POI), an interruption of bowel motility function, virtually occurs in all patients undergoing major gastrointestinal(GI) surgery. This functional impairment persists for a variable duration, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. Therefore, time of return of colonic function is the the major determinant of duration of POI. Attempts to reduce the duration of POI have prompted the implementation of fast track surgery including early removal of the nasogastric tube, early feeding, alvimopan, gum chewing, and prompt ambulation. However, it is still reported to be more than 4-5 days in most of the randomized trial. Therefore, methods specifically aiming at promoting postoperative colon motility may further enhance the GI function recovery, and prucalopride may be one of the options. Prucalopride, a substituted benzamide with selective 5-HT4 agonist activity, has been shown previously to significant improve colon motility and transit, but it only has mild effect on gastric or small bowel transit. The drug is well tolerated with no significant adverse effects. Recently, prucalopride has been approved in Europe and America for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. However, its usage in the postoperative period has not been tested. This study will test the ability and safety of prucalopride given 24hrs after GI surgery to hasten the recovery of GI function.

Conditions

• Postoperative Ileus

Interventions

Type	Name	Description
DRUG	Prucalopride	Prucalopride, 2mg, tablet. First given 24 hours after surgery beginning on POD 1,until bowel movements or for a maximum of 7 days of postoperative treatment
DRUG	Placebo	Vitamin, 50mg, tablet.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-12-09
• Last updated: 2016-09-30

Locations

1 site across 1 country: China