Outcomes Of Single-Layer Extramucosal Colostomy Closure With Full-Thickness (All-Layers) Colostomy Closure

NCT07411885 | Completed

• 1 other identifier: adeel 9
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

to compare the clinical outcomes of single-layer extramucosal colostomy closure with full-thickness (all-layers) colostomy closure in paediatric patients. Materials and Methods: This randomised controlled trial was conducted in the Department of Paediatric Surgery, Bahawal Victoria Hospital, Bahawalpur, from March 2021 to March 2022. A total of 52 paediatric patients undergoing colostomy reversal for anorectal malformations, intestinal obstruction, or blunt abdominal trauma were enrolled. They were randomly allocated into two groups: Group A underwent full-thickness colostomy closure, whereas Group B underwent single-layer extramucosal closure. Patients were followed for 30 days postoperatively. Primary outcomes included anastomotic leak and anastomotic stricture. Secondary outcomes included operative time and duration of hospital stay. Statistical analysis was performed using SPSS 21, with p ≤0.05 considered significant.

Conditions

Anastomosis, Leaking; Anastomotic Stenosis

Outcome Measures

Primary Outcomes (1)

• anastomosis leakage

  leakage assessed by pneumoperitineum and abdominal signs

  7 Days

Study Arms (2)

extramucosal closure

EXPERIMENTAL

colostomy closure done with extramucosal suturing

Procedure: extramucasal colostomy closure

full thickness

EXPERIMENTAL

colostomy closure done with full thickness suturing

Procedure: full thickness closure

Interventions

extramucasal colostomy closure PROCEDURE

stoma closed with extramucosal sutures

extramucosal closure

full thickness closure PROCEDURE

stoma closed with full thickness sutures

full thickness

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age ≤12 years
• Both genders
• Colostomy for:
• Anorectal malformations
• Intestinal obstruction
• Blunt abdominal trauma

You may not qualify if:

• Neonates and infants
• Multiple congenital anomalies
• Complicated prior surgery
• Patients unfit for general anaesthesia

Sponsors & Collaborators

• Children Hospital and Institute of Child Health, Lahore: lead

Study Sites (1)

CHUCHS, Lahore

Lahore, Punjab Province, 42000, Pakistan

Location

Related Publications (1)

• Mirza B, et al. Stoma reversal outcomes. J Pediatr Surg Case Rep. 2020.

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: post op assessor was blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: one with extramucosal closure and second group with full thickness closure

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: February 17, 2026
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 17, 2026

Record last verified: 2025-08

Locations

PA (1)