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

NCT06816407 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-03-19

No results posted yet for this study

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.

Conditions

  • Post-Op Complication

Interventions

DRUG

Prucalopride 2mg

Prucalopride 2mg taken preoperatively

DRUG

Prucalopride 4mg

Prucalopride 4mg taken preoperatively

OTHER

Standard Care

Standard Supportive care

Sponsors & Collaborators

  • Future University in Egypt

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-02
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06816407 on ClinicalTrials.gov