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

March 15, 2025 updated by: Nouran Omar El Said, Future University in Egypt

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control arm
Standard care
Other: Standard Care
Standard Supportive care
Experimental: Prucalopride 2mg
Other: Standard Care
Standard Supportive care
Drug: Prucalopride 2mg
Prucalopride 2mg taken preoperatively
Experimental: Prucalopride 4mg
Other: Standard Care
Standard Supportive care
Drug: Prucalopride 4mg
Prucalopride 4mg taken preoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to first stool
Time Frame: 7 days
7 days
time to tolerance of food
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
time to first flatus
Time Frame: 7 days
7 days
incidence of prolonged postoperative ileus
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 15, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM000186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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