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

Recruiting

• Conditions: Bowel Dysfunction

• Registration Number: NCT05716230
• Lead Sponsor: Nanjing Children's Hospital

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 Timeline

• Study Start: 2022-11-20
• Status Verified: 2023-01
• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-28
• Last Update Submitted: 2023-01-28
• Primary Completion: 2023-01-29
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Anorectal malformation >4 years old

Exclusion Criteria

Down syndrome patients <4 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bowel function score in partipants with ARM	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 Outcome Measures

Name	Time	Method
Sacral ratio in partipants with ARM	through study completion, an average of 6 year	test by X ray

Trial Locations

Locations (1)

Children's Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China