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临床试验/NCT06419998
NCT06419998已完成不适用

One Stage Transanal Versus One Stage Laparoscopic-assisted Transanal Endorectal Pull-through in the Management of Hirschsprung's Disease in Pediatric Age Group; A Retrospective Study.

Egyptian Biomedical Research Network2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
Post-operative enterocolitis

研究概览

简要总结

The goal of this clinical trial is to compare the surgical and functional outcomes of pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT) in pediatric patients presented with Hirschsprung's Disease between 3 months and 18 years old.

The main questions our study aims to answer are:

  • Does post-operative continence differs between the two groups?
  • Does post-operative constipation differs between the two groups?
  • Does post-operative soiling differs between the two groups
  • Does post-operative enterocolitis differs between the two groups?
  • Do post-operative complications differ between the two groups? If there is a comparison group: Researchers will compare between pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT) to see if there is a difference in post-operative continence, constipation, soiling, enterocolitis or complications.

Participants will be divided into two groups; 40 patients will be treated by TAERPT and included in Group A and 30 patients will be treated by LAERPT and included in Group B.

详细描述

Introduction

One-stage treatment of endorectal pull-through for Hirschsprung's disease could be approached through a complete transanal approach or with the assistance of laparoscopy. Our study aims to compare the surgical and functional outcomes of pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT). Material & methods: This retrospective study included 70 pediatric patients presented with Hirschsprung's Disease to Elshatby University Hospital. 40 patients were treated by TAERPT and included in Group A and 30 patients were treated by LAERPT and included in Group B. The two groups were compared as regards the operative data as well as the post-operative outcomes including the time of passage of stools, time of tolerating oral feeding, the duration of hospital stay, and the development of any early postoperative complications. Also, the number of bowel habits, constipation, enterocolitis, abdominal distension, anastomotic stricture, and continence were assessed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • * Pediatric patients with age range between 3 months and 18 years old presented with Hirschsprung's Disease who were confirmed to have this condition by contrast enema and/or rectal biopsy.

排除标准

  • Patients with previous colostomy.

结局指标

主要结局

Post-operative enterocolitis

时间窗: One post-operative year

The two groups will be compared according to post-operative enterocolitis whether present or not

Post-operative complications

时间窗: One post-operative year

The two groups will be compared according to post-operative complications whether present or not

Post-operative continence

时间窗: One post-operative year

The two groups will be compared according to post-operative continence whether continent or incontinent by using Abbreviated Baylor Social Continence Scale. the sore ranges from 0 to 24 with the minimum score revealing an excellent result and the highest score revealing the worst result. (Excellent = 0-5, Good = 7-12, Fair = 13-18, Poor = 19-24)

Post-operative constipation

时间窗: One post-operative year

The two groups will be compared according to post-operative constipation whether present or not

Post-operative soiling

时间窗: One post-operative year

The two groups will be compared according to post-operative soiling whether present or not

次要结局

未报告次要终点

研究者

发起方
Egyptian Biomedical Research Network
申办方类型
Network
责任方
Principal Investigator
主要研究者

Ahmed Elrouby

Associate Professor of pediatric Surgery

Egyptian Biomedical Research Network

研究点 (2)

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