Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery

NCT ID: NCT02004652

Last Updated: 2016-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-12-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Prucalopride

Intervention Type: DRUG

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

Placebo

Vitamin C, 50mg, tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Vitamin, 50mg, tablet.

Interventions

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

Intervention Type: DRUG

Placebo

Vitamin, 50mg, tablet.

Intervention Type: DRUG

Other Intervention Names

Resolor

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Jianfeng Gong

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianfeng Gong, MD

Role: PRINCIPAL_INVESTIGATOR

Department of general surgery,Jinling hospital

Locations

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, China

Countries

China

References

Gong J, Xie Z, Zhang T, Gu L, Yao W, Guo Z, Li Y, Lu N, Zhu W, Li N, Li J. Randomised clinical trial: prucalopride, a colonic pro-motility agent, reduces the duration of post-operative ileus after elective gastrointestinal surgery. Aliment Pharmacol Ther. 2016 Apr;43(7):778-89. doi: 10.1111/apt.13557. Epub 2016 Feb 15.

Reference Type: DERIVED

PMID: 26880227 (View on PubMed)

Other Identifiers

RIGS-2013-PRU

Identifier Type: -

Identifier Source: org_study_id