Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004652
• Other study ID #: RIGS-2013-PRU
• Status: Completed
• Phase: Phase 2
• First received: November 26, 2013
• Last updated: September 29, 2016
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: September 2016
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

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
• Placebo
Vitamin, 50mg, tablet.

Locations

Country	Name	City	State
China	Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Whole blood white blood cell(WBC) count on postoperative day 1 and 3	whole blood white blood cell (WBC) count(*109/L)	postoperative day 1 and 3	No
Other	Whole blood neutrophil percentage on postoperative day 1 and 3	neutrophil percentage(%)	postoperative day 1 and 3	No
Other	Whole blood platelet level on postoperative day 1 and 3	platelet level(*109/L)	postoperative day 1 and 3	No
Other	Serum C-reactive protein(CRP) level on postoperative day 1 and 3.	CRP level(mg/dL)	postoperative day 1 and 3	No
Other	Serum interleukin-6(IL-6) level on postoperative day 1 and 3.	IL-6(pg/ml)	postoperative day 1 and 3	No
Other	Serum procalcitonin(PCT) level on postoperative day 1 and 3.	PCT(ug/L)	postoperative day 1 and 3	No
Primary	Time to defaecation, measured in hours, from the time the surgery ends till the first observed passage of stool		up to 30 days after surgery	No
Secondary	Time of first passing flatus reported by the patients(hours)		up to 30 days after surgery	No
Secondary	Time to resume solid diet or total enteral nutrition(TEN)(days)		up to 30 days after surgery	No
Secondary	Length of postoperative hospital stay (LOS)(days)		participants will be followed for the duration of postoperative hospital stay, an expected average of 8 days	No
Secondary	Overall post-operative complication rate defined according to the Clavien-Dindo Classification		up to 30 days after surgery	No
Secondary	Overall cost (RMB)		participants will be followed for the duration of postoperative hospital stay, an expected average of 8 days	No
Secondary	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)		up to postoperative day 3	No
Secondary	Time to walk independently(days)		up to 30 days after surgery	No
Secondary	Hospital Readmission Rates Post 30-day Discharge		up to 30 days after discharge	No
Secondary	Length of postoperative ICU stay (days)		up to 30 days after surgery	No
Secondary	Incidence of adverse events related to drug usage	Diarrhoea,Flatulence,Nausea,Abdominal pain,Headaches,Menstrual disorder,Dizziness ,Skeletal pain,ECG nodal arrhythmia	up to 7 days after drug usage	Yes
Secondary	Reinsertion of nasogastric tube		up to 30 days after surgery	No