NCT06816407 Impact of Varying Doses of Prucalopride on Improving Gut Function Recovery After Elective Colorectal Surgery
| NCT ID | NCT06816407 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Future University in Egypt |
| Condition | Post-Op Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-03-02 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 180 participants in total. It began in 2025-03-02 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Postoperative ileus (POI) is a common complication after abdominal surgery, causing symptoms like nausea, vomiting, abdominal distension, and delayed passage of flatus and stool. Management remains challenging, with limited pharmacological options available. Prucalopride, a selective serotonin 5-HT4 receptor agonist, has shown promise in accelerating gastrointestinal recovery after surgery. However, the optimal timing and dosing for preventing POI remains unclear. Higher doses may provide more potent prokinetic effects in the postoperative setting. his study investigates if higher doses of prucalopride (4 mg) improve bowel function return and hospital stay in elective colorectal surgery patients compared to standard doses and placebo.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06816407 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Post-Op Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06816407 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 180 participants.
Is NCT06816407 currently recruiting?
Yes, NCT06816407 is actively recruiting participants. Contact the research team at amireskanderhanna@gmail.com for enrollment information.
Where is the NCT06816407 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06816407 clinical trial?
NCT06816407 is sponsored by Future University in Egypt. The trial plans to enroll 180 participants.