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

Phase 3

Recruiting

• Conditions: Post-Op Complication
• Interventions: Drug: Prucalopride 2mg; Other: Standard Care; Drug: Prucalopride 4mg

• Registration Number: NCT06816407
• Lead Sponsor: Future University in Egypt

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-07
• Study First Posted: 2025-02-10
• Status Verified: 2025-03
• Study Start: 2025-03-02
• Last Update Submitted: 2025-03-15
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prucalopride 2mg	Prucalopride 2mg	Prucalopride 2mg
Control arm	Standard Care	Standard care
Prucalopride 2mg	Standard Care	Prucalopride 2mg
Prucalopride 4mg	Prucalopride 4mg	Prucalopride 4mg
Prucalopride 4mg	Standard Care	Prucalopride 4mg

Primary Outcome Measures

Name	Time	Method
time to tolerance of food	7 days
time to first stool	7 days

Secondary Outcome Measures

Name	Time	Method
incidence of prolonged postoperative ileus	7 days
time to first flatus	7 days

Trial Locations

Locations (1)

Matareya Hospital; 🇪🇬 Cairo, Egypt