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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-02

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-Op Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control arm

Standard care

Group Type PLACEBO_COMPARATOR

Standard Care

Intervention Type OTHER

Standard Supportive care

Prucalopride 2mg

Group Type EXPERIMENTAL

Prucalopride 2mg

Intervention Type DRUG

Prucalopride 2mg taken preoperatively

Standard Care

Intervention Type OTHER

Standard Supportive care

Prucalopride 4mg

Group Type EXPERIMENTAL

Prucalopride 4mg

Intervention Type DRUG

Prucalopride 4mg taken preoperatively

Standard Care

Intervention Type OTHER

Standard Supportive care

Interventions

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Prucalopride 2mg

Prucalopride 2mg taken preoperatively

Intervention Type DRUG

Prucalopride 4mg

Prucalopride 4mg taken preoperatively

Intervention Type DRUG

Standard Care

Standard Supportive care

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No