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NCT Number: NCT02004652

Prucalopride for 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.

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Key information

Conditions

Postoperative Ileus Digestive System Diseases Gastrointestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Nanjing, Jiangsu, 210002, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

prucalopride

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

Other names: Resolor

Placebo

Drug

Vitamin, 50mg, tablet.

Primary outcomes

  1. 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

Secondary outcomes

  1. Time of first passing flatus reported by the patients(hours)

    Time frame: up to 30 days after surgery

  2. Time to resume solid diet or total enteral nutrition(TEN)(days)

    Time frame: up to 30 days after surgery

  3. 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

  4. Overall post-operative complication rate defined according to the Clavien-Dindo Classification

    Time frame: up to 30 days after surgery

  5. Overall cost (RMB)

    Time frame: participants will be followed for the duration of postoperative hospital stay, an expected average of 8 days

  6. 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

  7. Time to walk independently(days)

    Time frame: up to 30 days after surgery

  8. Hospital Readmission Rates Post 30-day Discharge

    Time frame: up to 30 days after discharge

  9. Length of postoperative ICU stay (days)

    Time frame: up to 30 days after surgery

  10. 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

  11. Reinsertion of nasogastric tube

    Time frame: up to 30 days after surgery

Other outcomes

  1. Whole blood white blood cell(WBC) count on postoperative day 1 and 3

    Time frame: postoperative day 1 and 3

    whole blood white blood cell (WBC) count(*109/L)

  2. Whole blood neutrophil percentage on postoperative day 1 and 3

    Time frame: postoperative day 1 and 3

    neutrophil percentage(%)

  3. Whole blood platelet level on postoperative day 1 and 3

    Time frame: postoperative day 1 and 3

    platelet level(*109/L)

  4. Serum C-reactive protein(CRP) level on postoperative day 1 and 3.

    Time frame: postoperative day 1 and 3

    CRP level(mg/dL)

  5. Serum interleukin-6(IL-6) level on postoperative day 1 and 3.

    Time frame: postoperative day 1 and 3

    IL-6(pg/ml)

  6. Serum procalcitonin(PCT) level on postoperative day 1 and 3.

    Time frame: postoperative day 1 and 3

    PCT(ug/L)

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2013
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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