Constipation Clinical Trial
Official title:
Bowel Function and Risk Factors for Bowel Dysfunction at Preschool and Early Childhood Age in Children With Hirschsprung Disease
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | August 30, 2023 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years and older |
Eligibility | Inclusion Criteria: 1. Clinical dignosis with Hirschsprung disease 2. completed the toilet training Exclusion Criteria: 1. redo-pull-through, 2. Down syndrome or other co-morbidities that impaired functional outcomes |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Weibing Tang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | bowel function score | 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. | through study completion, an average of 5 year | |
Primary | Clavien-Dindo classifification of surgical complications | 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) | through study completion, an average of 5 year | |
Primary | Hirschsprung disease associated enterocolitis(HAEC) | 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 [grade?]; and severe HAEC [grade ?]. | through study completion, an average of 5 year |
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