Clinical Trial: Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Jinling Hospital, China

Current Primary Outcome: Time to defaecation, measured in hours, from the time the surgery ends till the first observed passage of stool [ Time Frame: up to 30 days after surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time of first passing flatus reported by the patients(hours) [ Time Frame: up to 30 days after surgery ]
  • Time to resume solid diet or total enteral nutrition(TEN)(days) [ Time Frame: up to 30 days after surgery ]
  • Length of postoperative hospital stay (LOS)(days) [ Time Frame: participants will be followed for the duration of postoperative hospital stay, an expected average of 8 days ]
  • Overall post-operative complication rate defined according to the Clavien-Dindo Classification [ Time Frame: up to 30 days after surgery ]
  • Overall cost (RMB) [ Time Frame: participants will be followed for the duration of postoperative hospital stay, an expected average of 8 days ]
  • Pain scores on visual analogue scale (from 0 which implies no pain at all, to 10 which implies the worst pain imaginable) on the first 3 postoperative days and postoperative analgesic requirement (number of doses on 50-mg Pethidine) [ Time Frame: up to postoperative day 3 ]
  • Time to walk independently(days) [ Time Frame: up to 30 days after surgery ]
  • Hospital Readmission Rates Post 30-day Discharge [ Time Frame: up to 30 days after discharge ]
  • Length of postoperative ICU stay (days) [ Time Frame: up to 30 days after surgery ]
  • Incidence of adverse events related to drug usage [ Time Frame: up to 7 days after drug usage ]
    Diarrhoea,Flatulence,Nausea,Abdominal pain,Headaches,Menstrual disorder,Dizziness ,Skeletal pain,ECG nodal arrhythmia
  • Reinsertion of nasogastric tube [ Time Frame: up to 30 days after surgery ]


Original Secondary Outcome: Same as current

Information By: Jinling Hospital, China

Dates:
Date Received: November 26, 2013
Date Started: November 2013
Date Completion:
Last Updated: September 29, 2016
Last Verified: September 2016