Pediatric Colostomy Reversal: Traditional Care vs. Enhanced Recovery After Surgery (NCT07206836) | Clinical Trial Compass
RecruitingNot Applicable
Pediatric Colostomy Reversal: Traditional Care vs. Enhanced Recovery After Surgery
Pakistan60 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range
2 Years – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with Colostomy
* Admitted for Reversal of colostomy
Exclusion Criteria:
* Patients with endocrinal abnormalities
* Patients with cardiac abnormalities
* Patients with spinal abnormalities
* Patients with bleeding abnormalities
* Patients who have undergone previous multiple abdominal surgeries
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is comparing traditional post-surgery care to an Enhanced Recovery After Surgery (ERAS) approach for colostomy reversal in children, can you explain what specific differences my child would experience depending on which group they're placed in?
2The trial's main goal is to measure how many days children stay in the hospital after the reversal — what does current evidence suggest about whether ERAS protocols actually shorten hospital stays for kids having this procedure, and what would that mean practically for our family?
3Since this is listed as a Phase NA study, meaning it's more of a care comparison than a drug trial, what does that tell us about the known safety of both approaches, and are there any additional risks tied to participating versus just receiving standard care at your hospital?
4If my child were enrolled, would the assignment to traditional care or ERAS be random, and if we were placed in the traditional care group, would we be missing out on something that's already considered better practice at other hospitals?
5Before considering this trial, is colostomy reversal itself something you'd recommend for my child at this stage, and would participating in this study change the timing or approach of that surgery in any way?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Length of Hospital Stay (Days)
Timeframe: From date of surgery through hospital discharge (an average of 3-14 days)