Comparison of the Effectiveness of ERAS Protocol (Enhanced Recovery After Surgery) Versus Traditional Care in Pediatric Ileostomy Reversal Surgery

September 15, 2026 updated by: Nisar Ahmad, Children Hospital Faisalabad

This study compares the Enhanced Recovery After Surgery (ERAS) protocol to traditional postoperative care in pediatric patients undergoing elective ileostomy reversal. The ERAS protocol uses a standardized approach to minimize surgical stress, lower complication rates, and improve recovery times.

Participants are randomly assigned to either the ERAS protocol group or the traditional care group. The main goal of this study is to measure and compare the average length of post-operative hospital stay between the two groups. Additional outcomes evaluated include post-procedure pain scores, time to bladder catheter removal, duration of intravenous fluids, time to start oral feeding, and time to mobilization.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Pediatric patients undergoing elective ileostomy reversal. Patients who previously had stoma formation for conditions such as Hirschsprung disease, necrotizing enterocolitis (NEC), or anorectal malformation (ARM).

Written informed consent obtained from parent/guardian.

Exclusion Criteria:

Emergency ileostomy reversal surgeries. Presence of severe systemic comorbidities or severe sepsis prior to surgery. Refusal to give consent.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: ERAS protocol
Pediatric patients undergoing elective ileostomy reversal managed under the Enhanced Recovery After Surgery (ERAS) protocol, featuring early mobilization, early oral feeding, early catheter removal, and multimodal analgesia.
Other: ERAS protocol
Enhanced Recovery After Surgery multimodal protocol involving early oral feeding, early catheter removal, early mobilization, and multimodal pain control Recovery after surgery
Active Comparator: Active comparator : Traditional care group
Pediatric patients undergoing elective ileostomy reversal managed under standard postoperative care routines, including traditional fasting periods, routine IV fluid management, and standard analgesia.
Other: Traditional care
Standard postoperative care protocol with conventional fasting, standard intravenous fluids, and routine pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Postoperative Hospital stay
Time Frame: From date of surgery up to 30 days
total duration of hospital stay recorded in days from the completion of surgery until discharge
From date of surgery up to 30 days
Length of postoperative Hospital Stay
Time Frame: date of surgery up to 30 days
total duration of hospital stay recorded in days from the completion of surgery until discharge
date of surgery up to 30 days

Collaborators and Investigators

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

Sponsor

Children 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 (Estimated)

September 15, 2026

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

September 10, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 15, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Children hospital Faisalabad

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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