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临床试验/NCT05655845
NCT05655845招募中不适用

Bowel Function and Risk Factors for Bowel Dysfunction at Preschool and Early Childhood Age in Children With Hirschsprung Disease

Weibing Tang1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年8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
Weibing Tang
入组人数
300
试验地点
1
主要终点
Hirschsprung disease associated enterocolitis(HAEC)

研究概览

简要总结

Bowel dysfunction has been proven as the most common complication after pull-through(PT) of Hirschsprung disease(HD) ,which may persist to adulthood and lead to social problems.The reason of bowel dysfunction is complicated and the risk factors were not defined.

详细描述

Hirschsprung disease (HD) is a distinctive congenital disease with the absence of ganglion cells in the distal intestine leads to distal bowel obstruction and defecation disorders. HD is a rare disease, with a reported incidence of 1:5,000, requiring proper surgical treatment for the maintenance of normal or near-normal bowel movement.To date, there is insufficient evidence to recommend a preferred or superior method for the surgical repair, and a pull-through with or without laparoscopy was the most common procedure for correction of HD,which may have faster recovery and less rate of complication compared to other surgical approaches.The short or long-term outcomes of HD have been deeply assessed in the past few years,and bowel dysfunction,consist of soling, incontinence and constipation, had been proven as the most common complication,which may be a ongoing issue and lead to social problems,which should not be ignored. Otherwise,there were many reports proved that poor bowel function in preschool and early childhood may lead to social problems and depression in adolescence or adult.Many factors may lead to bowel dysfunction in HD, including length of aganglionic segement,anastomotic leakage or redo-PT,unsuitable timing of surgery,etc.Thus,the present study was designed to seek the risk factors for bowel dysfunction of HD,which is meaningful to maintain or improve the bowel function in preschool and early childhood.

研究设计

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

入排标准

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

入选标准

  • Clinical dignosis with Hirschsprung disease
  • completed the toilet training

排除标准

  • redo-pull-through,
  • Down syndrome or other co-morbidities that impaired functional outcomes

结局指标

主要结局

Hirschsprung disease associated enterocolitis(HAEC)

时间窗: through study completion, an average of 5 year

The guidelines for the diagnosis and management of HAEC were defined by the American Pediatric Surgical Association in 2017. There are three types of HAEC defined by severity: possible HAEC \[grade I\]; definite HAEC \[gradeⅡ\]; and severe HAEC \[grade Ⅲ\].

bowel function score

时间窗: through study completion, an average of 5 year

Bowel function score(BFS,total 20 points) was approved by Rintala in 1995 and patients with a score \> 17 were considered to have normal bowel habits. 7 items were in BFS,including ability to hold back defecation,feels/reports the urge to defecate,frequency of defecation,soiling,accidents,constipation.

Clavien-Dindo classifification of surgical complications

时间窗: through study completion, an average of 5 year

Clavien-Dindo is an objective grading system, which is used for grading postoperative complications in a reproduceable manner.It consists of five grades ranging from any deviation from a normal postoperative course (Grade I) to death (Grade V)

次要结局

未报告次要终点

研究者

发起方
Weibing Tang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Weibing Tang

Clinical Professor

Nanjing Children's Hospital

研究点 (1)

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