Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Undergoing elective colorectal surgery, including but not limited to colectomy, rectal resection, and sigmoid resection
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here