Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
ID06816407

The Effect of Different Doses of Prucalopride on Improving Gut Function Recovery Following Elective Colorectal Surgery: a Randomized, Double-blind Study

Led by Future University in Egypt · Updated on 2025-03-19

180

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Postoperative ileus (POI) is a common problem after abdominal surgery, especially colorectal operations, causing symptoms like nausea, vomiting, bloating, and delayed bowel movements. Managing POI is difficult, with few drug options available. This research evaluates if higher doses of prucalopride, a selective serotonin 5-HT4 receptor agonist, can help improve bowel function and shorten hospital stay after elective colorectal surgery, comparing 4 mg and 2 mg doses with placebo. Participants will be randomly assigned to receive either standard care, prucalopride 2 mg, or prucalopride 4 mg taken before surgery. The study is double-blind, meaning neither participants nor researchers know who receives which treatment. The goal is to see if the higher 4 mg dose leads to faster recovery of gut function and reduced hospital time compared to the lower dose or no prucalopride. During the trial, participants will be monitored for the time it takes to pass their first stool and tolerate food within 7 days after surgery. Additional outcomes include time to first gas passage and incidence of prolonged POI. The study includes careful evaluations and follows patients for one week post-operation to assess recovery speed and safety. The total participation spans this immediate postoperative period, focusing on gut function return and hospital stay length.

CONDITIONS

Brief Title

Impact of Varying Doses of Prucalopride on Improving Gut Function Recovery After Elective Colorectal Surgery

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing elective colorectal surgery, including but not limited to colectomy, rectal resection, and sigmoid resection
Not Eligible

You will not qualify if you...

  • Emergency surgery
  • Total colectomy
  • Creation of a stoma
  • Pre-existing gastrointestinal disorders
  • Severe renal or hepatic impairment
  • Known hypersensitivity to prucalopride

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - Up to 7 days after surgery

Participants receive prucalopride at varying doses or standard supportive care starting before elective colorectal surgery to improve gut function recovery.

Daily assessments during hospital stay for up to 7 days

Trial Site Locations

Total: 1 location

1

Matareya Hospital

Cairo, Egypt

Actively Recruiting

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Research Team

A

Amir Samy Hanna

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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