CHUCHS, Lahore
Lahore, Punjab Province, 42000, Pakistan
NCT Number: NCT07411885
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.
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Notify Me1 year–12 year
All sexes
Interventional
Not applicable
Lahore, Punjab Province, 42000, Pakistan
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
All patients underwent:
Operative technique Under general anaesthesia, the colostomy was mobilised. After confirming patency, bowel ends were prepared for anastomosis.
Primary outcomes:
Secondary outcomes:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
stoma closed with extramucosal sutures
stoma closed with full thickness sutures
Time frame: 7 Days
leakage assessed by pneumoperitineum and abdominal signs
Children Hospital and Institute of Child Health, Lahore
Other
Comparison of Outcomes Of Single-Layer Extramucosal Colostomy Closure With Full-Thickness (All-Layers) Colostomy Closure In Paediatric Patients
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