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

NCT ID: NCT05716230

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-20
• Study Completion Date: 2023-02-28

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.

Conditions

Bowel Dysfunction

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

bowel function score questionnaire survey

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 the ability to hold back defecation, feeling/reporting the urge to defecate, frequency of defecation, soiling, accidents, constipation. In December 2022, BFS questionnaire surveys were conducted on children with ARM who underwent surgical repair between January 2017 and December 2019 at Children's Hospital of Nanjing Medical University.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Anorectal malformation >4 years old

Exclusion Criteria

Down syndrome patients <4 years

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Weibing Tang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weibing Tang, Dr

Role: STUDY_DIRECTOR

Children's Hospital of Nanjing Medical University

Locations

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Changgui Lu, Dr

Role: CONTACT

luchanggui1984@163.com

13770848448

Facility Contacts

Changgui Lu

Role: primary

luchanggui1984@163.com

13770848448

References

Lu C, Pan S, Chen H, Tang W. Bowel function and features of bowel dysfunction in preschool children with anorectal malformation type rectoperineal and rectovestibular fistula. Eur J Pediatr. 2024 Feb;183(2):599-610. doi: 10.1007/s00431-023-05306-4. Epub 2023 Nov 8.

Reference Type: DERIVED

PMID: 37935997 (View on PubMed)

Other Identifiers

NanjingCH0109

Identifier Type: -

Identifier Source: org_study_id