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

NCT ID: NCT07206836

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-11-30

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.

Detailed Description

This single-center, prospective randomized controlled trial will compare two perioperative care strategies for pediatric colostomy reversal: the Enhanced Recovery After Surgery (ERAS) protocol and the conventional Traditional Care Protocol (TCP). The study is being conducted in the Department of Pediatric Surgery at the Children's Hospital and Institute of Child Health, Faisalabad, Pakistan.

Scientific Rationale

Colostomy reversal restores bowel continuity after temporary fecal diversion, which is frequently performed in children with anorectal malformations (ARM), Hirschsprung's disease (HD), or following severe perineal injury. Conventional postoperative care has historically included three days of mechanical bowel preparation, prolonged pre-operative fasting, routine nasogastric decompression, opioid-based analgesia, and delayed oral feeding. Evidence from both adult and pediatric literature shows that ERAS protocols-emphasizing minimal bowel preparation, shortened fasting, multimodal non-opioid analgesia, and early enteral feeding-can reduce hospital stay and enhance recovery without increasing complications. However, high-quality pediatric data, especially from South Asia, remain limited.

Study Design

The trial will enroll 60 children (ages 2-13 years) who meet inclusion criteria and have no major comorbidities or prior extensive abdominal surgery. Using a computer-generated randomization table, participants will be allocated in a 1:1 ratio to either the ERAS or TCP arm. The allocation will occur after informed consent from parents or guardians.

ERAS arm:

Pre-operative preparation consists of two rectal enemas and oral laxative 12 hours apart on the day before surgery.

Clear oral fluids are allowed until three hours prior to anesthesia.

Intraoperative management includes minimal bowel handling and caudal block for pain control.

Postoperative care features avoidance of opioid analgesia, removal of nasogastric tube within 48 hours, and initiation of clear oral fluids followed by early progression to solid diet as tolerated.

Traditional Care arm:

Mechanical bowel preparation and clear fluid diet for three days before surgery.

Overnight fasting and intra-venous antibiotics are given.

Postoperative management includes routine nasogastric decompression with a nil-per-mouth regimen for at least three days, opioid analgesia, and gradual reintroduction of oral intake starting on postoperative day three or four.

All operations will be performed by consultant pediatric surgeons with at least five years of post-FCPS experience to ensure procedural consistency.

Data Collection and Analysis

Daily postoperative assessments will include vital signs, abdominal examination, and tolerance of oral intake. Laboratory evaluation on postoperative day one will include complete blood count and serum electrolytes, with corrections as indicated. The primary endpoint is length of hospital stay, defined as the number of days from surgery to discharge once the child consumes at least one age-appropriate solid meal without vomiting for six hours. Data will be entered in SPSS version 25. Quantitative variables will be summarized as means and standard deviations; qualitative variables as frequencies and percentages. Independent-sample t tests will compare the primary outcome between groups. Age, gender, and underlying diagnosis will be assessed as potential effect modifiers through stratification followed by post-stratification t tests. A p-value ≤0.05 will be considered statistically significant.

Significance

This study addresses a key evidence gap by providing randomized controlled data on ERAS in a high-volume pediatric surgical setting in Punjab, Pakistan. Demonstrating a reduction in hospital stay without added complications could support broader adoption of ERAS protocols, improving patient turnover, reducing healthcare costs, and enhancing recovery for children undergoing colostomy reversal.

Conditions

Colostomy - Stoma; Stoma Reversal Procedure; ERAS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enhanced Recovery after Surgery (ERAS)

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.

Group Type: EXPERIMENTAL

Enhanced Recovery after Surgery Protocol

Intervention Type: OTHER

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

Traditional Care Protocol

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.

Group Type: ACTIVE_COMPARATOR

Traditional Care Protocol

Intervention Type: 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.

Interventions

Enhanced Recovery after Surgery Protocol

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

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

ERAS

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children Hospital Faisalabad

OTHER

Sponsor Role: lead

Responsible Party

Salman Ali

Post-Graduate Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children Hospital and Institute of Child Health Faisalabad

Faisalābad, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Salman Ali, MBBS

Role: CONTACT

SalmanAli@live.com

+923000680882

Facility Contacts

Naveed Irshad, MBBS

Role: primary

+92 334 0671331

Other Identifiers

696/CH&ICH/FSD

Identifier Type: -

Identifier Source: org_study_id