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Clinical Trials/NCT05716230
NCT05716230RecruitingNot Applicable

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

Nanjing Children's Hospital1 site in 1 country150 target enrollmentStarted: November 20, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
bowel function score in partipants with ARM

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Case Crossover
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
4 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Anorectal malformation >4 years old

Exclusion Criteria

  • •Down syndrome patients <4 years

Outcomes

Primary Outcomes

bowel function score in partipants with ARM

Time Frame: 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

Secondary Outcomes

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

Investigators

Sponsor
Nanjing Children's Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Weibing Tang

Director

Nanjing Children's Hospital

Study Sites (1)

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