RecruitingPhase 3NCT06816407

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

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


Sponsor

Future University in Egypt

Enrollment

180 participants

Start Date

Mar 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

  • undergoing elective colorectal surgery, including but not limited to colectomy, rectal resection, and sigmoid resection.

Exclusion Criteria6

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

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Interventions

DRUGPrucalopride 2mg

Prucalopride 2mg taken preoperatively

DRUGPrucalopride 4mg

Prucalopride 4mg taken preoperatively

OTHERStandard Care

Standard Supportive care


Locations(1)

Matareya Hospital

Cairo, Egypt

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NCT06816407


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