Actively Recruiting

Phase Not Applicable
Age: 2Years - 13Years
All Genders
ID07206836

Comparison of Outcome of Colostomy Reversal in Pediatric Patients With Enhanced Recovery After Surgery Versus Traditional Care Protocols

Led by Children Hospital Faisalabad · Updated on 2025-10-03

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial focuses on children aged 2 to 13 years undergoing colostomy reversal surgery. It aims to determine whether an Enhanced Recovery After Surgery (ERAS) protocol helps children recover faster and reduces their hospital stay compared to traditional care. The study addresses a gap in pediatric surgical care, especially in South Asia, by assessing if ERAS can improve recovery without added complications. Participants are randomly assigned to one of two care strategies before and after their surgery. The ERAS group will experience shorter fasting times, no mechanical bowel cleansing, early pain control using non-opioid methods, and early feeding after surgery. The traditional care group will follow the usual longer bowel preparation, overnight fasting, opioid pain medications, nasogastric tube placement, and delayed food intake. Experienced pediatric surgeons will perform all surgeries. Children will be closely monitored daily after surgery until they can eat a solid meal without vomiting, which marks when they can leave the hospital. Assessments include vital signs, abdominal exams, blood tests, and feeding tolerance. The main measure of success is the length of hospital stay from surgery until discharge. Data will be analyzed to compare outcomes between the two care approaches, considering factors like age and diagnosis.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 2Years - 13Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with Colostomy
  • Admitted for Reversal of colostomy
  • Aged between 2 and 13 years
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 3 to 14 days

Participants undergo colostomy reversal surgery with perioperative care according to either the Enhanced Recovery After Surgery (ERAS) protocol or the Traditional Care Protocol (TCP). Postoperative management includes pain control, nasogastric tube management, and initiation of oral intake as per assigned protocol.

Daily in-hospital assessments

Post-operative Follow-up

Duration - Until hospital discharge within 3 to 14 days post-surgery

Participants are monitored until discharge once they tolerate at least one age-appropriate solid meal without vomiting for six hours.

Daily visits until discharge

Trial Site Locations

Total: 1 location

1

Children Hospital and Institute of Child Health Faisalabad

Faisalābad, Punjab Province, Pakistan

Actively Recruiting

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Research Team

S

Salman Ali, MBBS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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