The Frequency of Anastomotic Leakage in Early and Delayed Oral Feeding Following Ileostomy Reversal Will be Compared

July 24, 2026 updated by: Maria Dilshad, Allied Hospital Faisalabad

Comparison of Frequency of Anastomotic Leakage in Early Versus Delayed Oral Feeding After Illeostomy Reversal

The purpose of of this study is to compare the frequency of anastomotic leakage in early versus delayed oral feeding following feeding after illeostomy reversal so early oral feeding can be encouraged.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of of this study is to encourage early oral feeding after stoma reversal, shorten the length of hospitalisation and reduce post operative morbidity and mortality

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Pakistan
    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan, 38000
        • Allied Hospital Faisalabad

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:

  • Patients undergoing elective ileostomy reversal surgery
  • age between 18 and 70 years
  • patient provided informed consent

Exclusion Criteria:

  • patients with active active peritonitis
  • Advanced malignancy
  • Patients requiring extensive bowel resection

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Early oral feeding
Patients receive oral liquids within or solid food within 24 hours after stoma reversal reversal surgery
Behavioral: Early oral feeding protocol
Patients receive oral liquids within or solid food within 24 hours after stoma reversal surgery
Active Comparator: Group 2 : Delayed oral feeding
Patients are kept NPO until the return of bowel function typically 48 to 72 hours postoperatively
Behavioral: Delayed oral feeding protocol
Patients are kept NPO until the return of bowel function typically 48 to 72 hours postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anastomotic leakage 7 days after surgery
Time Frame: Within 14 days post operatively
Within 14 days post operatively

Collaborators and Investigators

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

Sponsor

Allied Hospital Faisalabad

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 30, 2026

Primary Completion (Actual)

July 20, 2026

Study Completion (Actual)

July 20, 2026

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

July 24, 2026

First Posted (Actual)

July 28, 2026

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Ref No. 48.ERC/FMU/2025-26/247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared publicly to protect patient confidentiality only aggregated study findings and statistical results will be made available through publication

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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