NCT06816407

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2025

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

March 2, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

February 4, 2025

Last Update Submit

March 15, 2025

Conditions

Post-Op Complication

Keywords

pro kineticgut function recovery

Outcome Measures

Primary Outcomes (2)

  • time to first stool

    7 days

  • time to tolerance of food

    7 days

Secondary Outcomes (2)

  • time to first flatus

    7 days

  • incidence of prolonged postoperative ileus

    7 days

Study Arms (3)

Control arm

PLACEBO COMPARATOR

Standard care

Other: Standard Care

Prucalopride 2mg

EXPERIMENTAL

Prucalopride 2mg

Drug: Prucalopride 2mgOther: Standard Care

Prucalopride 4mg

EXPERIMENTAL

Prucalopride 4mg

Drug: Prucalopride 4mgOther: Standard Care

Interventions

Prucalopride 2mgDRUG

Prucalopride 2mg taken preoperatively

Prucalopride 2mg
Prucalopride 4mgDRUG

Prucalopride 4mg taken preoperatively

Prucalopride 4mg
Standard CareOTHER

Standard Supportive care

Control armPrucalopride 2mgPrucalopride 4mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Matareya Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Interventions

prucaloprideStandard of Care

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Amir Samy Hanna

CONTACT

01227933624amireskanderhanna@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 10, 2025

Study Start

March 2, 2025

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)