Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery

Jinling Hospital, China

Status and phase: Completed; Phase 2

Conditions: Postoperative Ileus

Treatments: Drug: Placebo; Drug: Prucalopride

Study type: Interventional

Funder types: Other

Identifiers

NCT02004652

RIGS-2013-PRU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Consecutive patients undergoing elective gastric, small bowel, or partial colonic resection via laparotomy or laparoscopy.
2. Patients with American Society of Anaesthesiologists grading I-III
3. Informed consent available.

Exclusion criteria

1. Patients with stoma creation, extensive adhesiolysis, total or subtotal colectomy , or patients who had a history of total or subtotal colectomy.
2. Patients who developed intraoperative problems or complications, or had peritoneal carcinomatosis.
3. Patients who developed serious complications within 24 hours after surgery.
4. Those who received epidural anesthesia or analgesia.
5. Patients who received other prokinetic drugs.
6. Patients who were allergic to prucalopride.
7. Patients with severe comorbidity and/or organ(kidney, liver, and heart) dysfunction
8. Patients had complete bowel obstruction
9. Patients who have participated other clinical trials.
10. Patients who have short bowel(<200cm small bowel) or history of constipation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

Prucalopride

Experimental group

Description:

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

Treatment:

Drug: Prucalopride

Placebo

Placebo Comparator group

Description:

Vitamin C, 50mg, tablet

Treatment:

Drug: Placebo