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临床试验/NCT05716230
NCT05716230招募中不适用

Bowel Function and Associated Risk Factors for Bowel Dysfunciton in Preschool and Early Childhood in Patients With Anorectal Malformation

Nanjing Children's Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
bowel function score in partipants with ARM

研究概览

简要总结

The present study was designed to evaluate bowel function in preschool and early childhood in a large number of patients with anorectal Malformation and to identify the associated risk factors for bowel dysfunction.

详细描述

Anorectal malformation (ARM) is a type of congenital malformation resulting from post-embryonic intestinal dysgenesis, occurring in about 1 in 5000 cases.Surgery is an effective means of treating ARM,which includes reconstruction of the anus and treatment of associated deformities. However, even with reconstruction of the anus, most children still have serious complications, such as constipation, fecal incontinence, urinary incontinence, and sexual dysfunction, in the mid-to-long postoperative period.A lot of studies have been designed to explore the trend toward normal bowel habits from preschool and early childhood age to adolescence or adult; however, no apparent improvement in bowel habits was completely confirmed. In contrast, many reports have shown that poor bowel function in preschool and early childhood may lead to social problems and depression in adolescence and adult.The reasons for bowel dysfunction of ARM in preschool and early childhood were complicated and undefined,including associated malformations, the type of ARM, and the development of the perianal sphincter,etc.The bowel function score (BFS) is currently used to assess mid- and long-term anal function in patients with ARM, and comprises seven major categories (e.g., self-perception, fecal control, stool collection, and social problems) with a total of 20 points, or less than 17 points, for the presence of anal weakness (11-17 points, for the general weakness, or less than 11 points, for the severe weakness) .Therefore,bowel function at preschool and early childhood should be evaluated in a large number of patients with ARM and the associated risk factors for bowel dysfunction should also be assessed. The present study was designed to evaluate bowel function in preschool and early childhood in a large number of patients with ARM and to identify the associated risk factors for bowel dysfunction using BFS.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
4 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Anorectal malformation >4 years old

排除标准

  • •Down syndrome patients <4 years

结局指标

主要结局

bowel function score in partipants with ARM

时间窗: through study completion, an average of 6 year

approved by Rintala in 1995, and patients with a score ≥ 17 were considered to have normal bowel habits

次要结局

  • Sacral ratio in partipants with ARM(through study completion, an average of 6 year)

研究者

发起方
Nanjing Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Weibing Tang

Director

Nanjing Children's Hospital

研究点 (1)

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