NCT02004652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

November 26, 2013

Last Update Submit

September 29, 2016

Conditions

Postoperative Ileus

Keywords

PrucaloprideGastrointestinal DiseasesPostoperative ileusRandomised trial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (11)

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

    up to 30 days after surgery

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

    up to 30 days after surgery

  • Length of postoperative hospital stay (LOS)(days)

    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

    up to 30 days after surgery

  • Overall cost (RMB)

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

  • +6 more secondary outcomes

Other Outcomes (6)

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

    postoperative day 1 and 3

  • Whole blood neutrophil percentage on postoperative day 1 and 3

    postoperative day 1 and 3

  • Whole blood platelet level on postoperative day 1 and 3

    postoperative day 1 and 3

  • +3 more other outcomes

Study Arms (2)

Prucalopride

EXPERIMENTAL

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

Drug: Prucalopride

Placebo

PLACEBO COMPARATOR

Vitamin C, 50mg, tablet

Drug: Placebo

Interventions

PrucaloprideDRUG

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

Also known as: Resolor
Prucalopride
PlaceboDRUG

Vitamin, 50mg, tablet.

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210002, China

Location

Related Publications (1)

  • 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.

    PMID: 26880227DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Jianfeng Gong, MD

    Department of general surgery,Jinling hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 9, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations

CN(1)