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

Comparison of Outcomes Of Single-Layer Extramucosal Colostomy Closure With Full-Thickness (All-Layers) Colostomy Closure In Paediatric Patients

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.

Study Overview

• Status: Completed
• Conditions: Anastomotic Stenosis; Anastomosis, Leaking
• Intervention / Treatment: Procedure: extramucasal colostomy closure; Procedure: full thickness closure

Detailed Description

INTRODUCTION Restoration of bowel continuity following colostomy requires meticulous intestinal anastomosis. The optimal technique continues to be debated, with the two commonly used methods being single-layer extramucosal anastomosis and full-thickness (all-layers) anastomosis. Historically, Halsted advocated extramucosal suturing and discouraged mucosal penetration, emphasising tissue preservation and improved healing. Contemporary literature supports single-layer techniques due to reduced tissue trauma, shorter operative time and lower cost, without compromising anastomotic integrity.

Colostomy reversal is frequently required in paediatric surgical practice, especially for anorectal malformations, Hirschsprung disease and intestinal perforations. Anastomotic leak remains the most critical postoperative complication, with rates reported between 1-7%. Leaks significantly increase morbidity, re-operation rates and hospital stay. Anastomotic stricture is another problematic long-term complication contributing to bowel obstruction.

Evidence suggests that single-layer extramucosal anastomosis may reduce luminal narrowing, preserve submucosal vascular plexus and provide comparable leak rates. However, data specific to paediatric colostomy closure remain limited.

This study was conducted to compare the effectiveness of single-layer extramucosal versus full-thickness colostomy closure in paediatric patients, focusing on operative time, anastomotic integrity and postoperative recovery.

________________________________________ MATERIALS & METHODS Study design and setting A randomised controlled trial was conducted in the Department of Paediatric Surgery, Bahawal Victoria Hospital, Bahawalpur, from March 2021 to March 2022.

Sample size and sampling A total of 52 patients (26 per group) were included. Sample size was calculated at 90% power and 95% confidence level. Patients were allocated into two groups through sealed-envelope randomisation.

Inclusion criteria

• Age ≤12 years
• Both genders

• Colostomy for:

  • Anorectal malformations
  • Intestinal obstruction
  • Blunt abdominal trauma Exclusion criteria
• Neonates and infants
• Multiple congenital anomalies
• Complicated prior surgery
• Patients unfit for general anaesthesia Preoperative assessment

All patients underwent:

• CBC
• LFTs
• Viral screening
• Serum electrolytes
• Distal loopogram Patients were kept NPO for 12 hours preoperatively and received rectal enemas. Prophylactic antibiotics were administered.

Operative technique Under general anaesthesia, the colostomy was mobilised. After confirming patency, bowel ends were prepared for anastomosis.

• Group A: Full-thickness (all-layers) anastomosis using inner full-thickness and outer seromuscular sutures.
• Group B: Single-layer interrupted extramucosal anastomosis using 3-0 Vicryl. Nasogastric decompression and standard postoperative monitoring were provided. Postoperative care and follow-up
• NG tube removed once bowel sounds returned
• Gradual reintroduction of oral feeds
• Patients discharged on oral antibiotics
• Follow-up at 7 days and 30 days Outcome measures

Primary outcomes:

• Anastomotic leak
• Anastomotic stricture

Secondary outcomes:

• Duration of operation
• Duration of hospital stay Statistical analysis SPSS 21.0 was used.
• Quantitative variables → mean ± SD, independent t-test
• Categorical variables → frequencies, percentages, Fisher exact test
• p ≤0.05 considered significant

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 42000
      • CHUCHS, Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Age ≤12 years

  • Both genders

  • Colostomy for:

    • Anorectal malformations
    • Intestinal obstruction
    • Blunt abdominal trauma

Exclusion Criteria:

• • Neonates and infants

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: extramucosal closure; colostomy closure done with extramucosal suturing	Procedure: extramucasal colostomy closure; stoma closed with extramucosal sutures
Experimental: full thickness; colostomy closure done with full thickness suturing	Procedure: full thickness closure; stoma closed with full thickness sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anastomosis leakage	leakage assessed by pneumoperitineum and abdominal signs	7 Days

Collaborators and Investigators

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

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: adeel 9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: will decide once sure

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No