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临床试验/NCT03174028
NCT03174028Unknown不适用

Laparoscopically Assisted Anorectal Pull-through Versus Posterior Sagittal Anorectoplasty for High and Intermediate Anorectal Malformations : A Comparative Study

Assiut University0 个研究点目标入组 30 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
stool continence

研究概览

简要总结

Anorectal malformations are congenital malformations, in which the terminal part of the hindgut is abnormally placed and lies outside (partially or completely) the sphincter mechanism.

详细描述

The incidence of anorectal malformation ~1 in 5,000 More common in Down's syndrome and Cat-eye syndrome. Male >female (60:40).It is classified into many types according to the degree of descent of the rectal pouch in the pelvis, the fistula between the rectum and the urinary system in males and genital system in females. The most common type in males is high anorectal malformation with rectourethral fistula

There are many historical operations for the management of the high type, but the most popular operation now is the posterior sagittal anorectoplasty which was published for the first time in 1982. Children undergoing posterior sagittal anorectoplasty may have lifelong bowel management problems of constipation, incontinence, and encopresis.

After the introduction of laparoscopy in pediatric surgery, many surgeons hope that the use of laparoscopy instead of posterior sagittal anorectoplasty may reduce the complications of the complications of the big incision and disturbance of sphincter mechanism which occur in posterior sagittal anorectoplasty operation. In addition to its role in diagnosis in complex anomalies like cloaca which is well established now. So the question is to what extent can the laparoscopy replace usual surgery for anorectal malformation.

研究设计

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

入排标准

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

入选标准

  • all male and female childs aged from 6 months to the age of 3 years, in assiut university hospital, who have been diagnosed to have high anorectal malformation since birth and for whom colostomy was done

排除标准

  • all cases with low anomalies will be excluded.
  • Female child with vestibular anus
  • case with short distal pouch

结局指标

主要结局

stool continence

时间窗: 3 months

questionaire about the degree of stool continence

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Gamal Abdelmalek

principle investigator

Assiut University

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