Bowel Function and Risk Factors for Bowel Dysfunction at Preschool and Early Childhood Age in Children With Hirschsprung Disease
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
- 否
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
Weibing Tang
Clinical Professor
Nanjing Children's Hospital
