Pediatric Colostomy Reversal: Traditional Care vs. Enhanced Recovery After Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-13
SponsorChildren Hospital Faisalabad
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with Colostomy
Admitted for Reversal of colostomy
Disqualifiers
Patients with endocrinal abnormalities
Patients with cardiac abnormalities
Patients with spinal abnormalities
Patients with bleeding abnormalities
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced Recovery after Surgery Protocol
Other interventionreduced fasting, no mechanical bowel prep, early feeding, non-opioid analgesia.
Traditional Care Protocol
Other interventionParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Enhanced Recovery after Surgery (ERAS)Experimental treatment 1 intervention
Group B: Traditional Care ProtocolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Length of Hospital Stay (Days)
Duration of hospitalization measured from the day of surgery until discharge.
Time frame
From date of surgery through hospital discharge (an average of 3-14 days)Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Children Hospital and Institute of Child Health FaisalabadRecruiting Faisalābad, Punjab Province
Pakistan
PakistanSponsors and contacts
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Source ClinicalTrials.gov