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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07411885
Enrollment
52
Registered
2026-02-17
Start date
2024-04-01
Completion date
2025-05-01
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomosis, Leaking, Anastomotic Stenosis

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.

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

Interventions

PROCEDUREextramucasal colostomy closure

stoma closed with extramucosal sutures

PROCEDUREfull thickness closure

stoma closed with full thickness sutures

Sponsors

Children Hospital and Institute of Child Health, Lahore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

post op assessor was blind

Intervention model description

one with extramucosal closure and second group with full thickness closure

Eligibility

Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
anastomosis leakage7 Daysleakage assessed by pneumoperitineum and abdominal signs

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026