Postoperative Ileus Clinical Trial
Official title:
A Randomized, Controlled, Double-blind Efficacy and Tolerability Study Of Prucalopride For The Treatment Of Postoperative Ileus In Patients Undergoing Gastrointestinal Surgery
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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