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NCT Number: NCT06816407

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

Postoperative ileus (POI) is a common complication after abdominal surgery, particularly colorectal procedures, which can delay recovery and prolong hospital stay. POI is characterized by a transient cessation of coordinated bowel motility, leading to symptoms such as nausea, vomiting, abdominal distension, and delayed passage of flatus and stool. Effective management of POI remains challenging, with limited pharmacological options available. Prucalopride, a highly selective serotonin 5-HT4 receptor agonist, has shown promise in accelerating gastrointestinal recovery after surgery. However, the optimal timing and dosing of prucalopride for preventing POI remains unclear. Studies have shown dose-dependent improvements in outcomes with doses up to 4 mg daily. Higher doses may provide more potent prokinetic effects in the postoperative setting, but no studies have examined doses above 2 mg for prevention of POI in colorectal surgery. The purpose of this study is to determine if higher doses of prucalopride (4 mg) result in faster return of bowel function and shorter hospital stay compared to the standard dose (2 mg) and placebo in patients undergoing elective colorectal surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prucalopride 2mg

Drug

Prucalopride 2mg taken preoperatively

Prucalopride 4mg

Drug

Prucalopride 4mg taken preoperatively

Standard care

Other

Standard Supportive care

Primary outcomes

  1. time to first stool

    Time frame: 7 days

  2. time to tolerance of food

    Time frame: 7 days

Secondary outcomes

  1. time to first flatus

    Time frame: 7 days

  2. incidence of prolonged postoperative ileus

    Time frame: 7 days

Study contacts

Contact information is provided by the study sponsor or research team.

Amir Samy Hanna

CONTACT

[email protected]

01227933624

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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