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

NCT07206836 | Recruiting

• 1 other identifier: 696/CH&ICH/FSD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pediatric Colostomy; Colostomy Reversal; Enhanced Recovery After Surgery; ERAS; Traditional Care protocol; Length of Hospital Stay

Outcome Measures

Primary Outcomes (1)

• Length of Hospital Stay (Days)

  Duration of hospitalization measured from the day of surgery until discharge.

  From date of surgery through hospital discharge (an average of 3-14 days)

Study Arms (2)

Enhanced Recovery after Surgery (ERAS)

EXPERIMENTAL

Patients undergoing colostomy reversal managed with the Enhanced Recovery After Surgery (ERAS) protocol, which emphasizes reduced fasting, avoidance of mechanical bowel preparation, early postoperative oral feeding, and multimodal non-opioid analgesia.

Other: Enhanced Recovery after Surgery Protocol

Traditional Care Protocol

ACTIVE COMPARATOR

Patients undergoing colostomy reversal managed with the traditional perioperative care protocol, including three days of mechanical bowel preparation, overnight fasting before surgery, routine nasogastric tube placement, opioid-based postoperative pain control, and delayed resumption of oral intake.

Other: Traditional Care Protocol

Interventions

Enhanced Recovery after Surgery Protocol OTHER

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

Also known as: ERAS

Enhanced Recovery after Surgery (ERAS)

Traditional Care Protocol OTHER

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.

Traditional Care Protocol

Eligibility Criteria

• Age: 2 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with Colostomy
• Admitted for Reversal of colostomy

You may not qualify if:

• Patients with endocrinal abnormalities
• Patients with cardiac abnormalities
• Patients with spinal abnormalities
• Patients with bleeding abnormalities
• Patients who have undergone previous multiple abdominal surgeries

Sponsors & Collaborators

• Children Hospital Faisalabad: lead

Study Sites (1)

Children Hospital and Institute of Child Health Faisalabad

Faisalābad, Punjab Province, Pakistan

RECRUITING

Central Study Contacts

Salman Ali, MBBS

CONTACT

+923000680882; SalmanAli@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Graduate Resident

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: October 3, 2025
• Study Start: August 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data and supporting documents (study protocol and statistical analysis plan) will be available beginning 6 months after publication of the primary results and for a period of 3 years thereafter
• Access Criteria: De-identified data will be shared with qualified researchers who submit a methodologically sound proposal to address a scientifically valid question. Requests should be sent to SalmanAli@live.com. Access will be granted after approval by the principal investigator and ethics committee. Data will be provided through a secure, password-protected platform for research use only and must not be used to re-identify participants.

Locations

PA (1)