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临床试验/NCT07411885
NCT07411885已完成不适用

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

Children Hospital and Institute of Child Health, Lahore1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
anastomosis leakage

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

post op assessor was blind

入排标准

年龄范围
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

extramucosal closure

Experimental

colostomy closure done with extramucosal suturing

干预措施: extramucasal colostomy closure (Procedure)

full thickness

Experimental

colostomy closure done with full thickness suturing

干预措施: full thickness closure (Procedure)

结局指标

主要结局

anastomosis leakage

时间窗: 7 Days

leakage assessed by pneumoperitineum and abdominal signs

次要结局

未报告次要终点

研究者

发起方
Children Hospital and Institute of Child Health, Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Adeel Ashiq

Principal Investigator

Children Hospital and Institute of Child Health, Lahore

研究点 (1)

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