Effects of Prucalopride on Gut Recovery After Colorectal Surgery
The Effect of Different Doses of Prucalopride on Improving Gut Function Recovery Following Elective Colorectal Surgery: a Randomized, Double-blind Study
This study is testing if a higher dose of prucalopride can help people recover their bowel function faster after colorectal surgery compared to a lower dose and a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Future University in Egypt Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06816407 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of varying doses of prucalopride, a selective serotonin 5-HT4 receptor agonist, on gut function recovery in patients undergoing elective colorectal surgery. It aims to determine whether a higher dose of 4 mg can accelerate bowel function return and reduce hospital stay compared to a standard dose of 2 mg and a placebo. The study addresses the common postoperative complication of ileus, which can delay recovery and prolong hospitalization. By examining the efficacy of different dosing regimens, the research seeks to optimize pharmacological management for postoperative ileus.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing elective colorectal surgeries such as colectomy or rectal resection.
Not a fit: Patients undergoing emergency surgeries, total colectomies, or those with pre-existing gastrointestinal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery times and reduced hospital stays for patients after colorectal surgery.
How similar studies have performed: Previous studies have shown promise with prucalopride in enhancing gastrointestinal recovery, but this specific dosing approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * undergoing elective colorectal surgery, including but not limited to colectomy, rectal resection, and sigmoid resection. Exclusion Criteria: * Emergency surgery * Total colectomy * Creation of a stoma * Pre-existing gastrointestinal disorders * Severe renal or hepatic impairment * Known hypersensitivity to prucalopride.
Where this trial is running
Cairo
- Matareya Hospital — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Amir Samy Hanna
- Email: amireskanderhanna@gmail.com
- Phone: 01227933624
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.