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Pediatric Colostomy Reversal: Traditional Care vs. Enhanced Recovery After Surgery

NCT07206836 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-03

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether using an Enhanced Recovery After Surgery (ERAS) protocol helps children recover faster after colostomy reversal compared with traditional care.

The main question it aims to answer is:

Does ERAS lower the number of days children need to stay in the hospital after colostomy reversal compared with traditional care?

Researchers will compare two groups:

ERAS group - Children receive shorter pre-surgery fasting, no mechanical bowel preparation, early pain control, and early feeding after surgery.

Traditional care group - Children receive the usual long bowel preparation, overnight fasting, opioid pain medicine, and a longer period without food after surgery.

Participants will:

Be randomly assigned to either the ERAS or traditional care group

Have their colostomy surgically closed by experienced pediatric surgeons

Be monitored daily until they can eat a solid meal without vomiting; this marks the end of their hospital stay

The study will enroll 60 children ages 2-13 at Children's Hospital Faisalabad, Pakistan.

Researchers will measure length of hospital stay from surgery until discharge as the main outcome.

Conditions

  • Colostomy - Stoma
  • Stoma Reversal Procedure
  • ERAS

Interventions

OTHER

Enhanced Recovery after Surgery Protocol

reduced fasting, no mechanical bowel prep, early feeding, non-opioid analgesia.

OTHER

Traditional Care Protocol

Participants receive standard peri-operative management for colostomy reversal. This includes three days of mechanical bowel preparation with oral laxatives and clear fluids, overnight fasting before surgery, routine nasogastric tube placement, opioid-based postoperative pain control, and a nil-per-mouth regimen for at least three days after surgery before gradually resuming oral intake.

Sponsors & Collaborators

  • Children Hospital Faisalabad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Pakistan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07206836 on ClinicalTrials.gov