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

Sponsor
Nanjing Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05716230
Collaborator
(none)
150
1
3.3
45.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: bowel function score questionnaire survey

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
Anticipated Enrollment :
150 participants
Observational Model:
Case-Crossover
Time Perspective:
Cross-Sectional
Official Title:
Bowel Function and Associated Risk Factors for Bowel Dysfunciton in Preschool and Early Childhood in Patients With Anorectal Malformation
Actual Study Start Date :
Nov 20, 2022
Actual Primary Completion Date :
Jan 29, 2023
Anticipated Study Completion Date :
Feb 28, 2023

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Sacral ratio in partipants with ARM [through study completion, an average of 6 year]

    test by X ray

Other Outcome Measures

  1. Number of partipants with every type of ARM [through study completion, an average of 6 year]

    confirmed in surgery

  2. age at surgery of partipants with ARM [through study completion, an average of 6 year]

    age at surger

  3. Number of partipants performed with every surgical method [through study completion, an average of 6 year]

    Posterior sagittal approach to anoplasty or Anterior sagittal approach to anoplasty or Laparoscopic assisted anoplasty

  4. Number of partipants with abnormal spinal cord [through study completion, an average of 6 year]

    tethered cord or other

  5. Number of partipants with reoperation [through study completion, an average of 6 year]

    re-anoplasty

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Anorectal malformation >4 years old

Exclusion Criteria:

Down syndrome patients <4 years

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Nanjing Medical University Nanjing Jiangsu China 210008

Sponsors and Collaborators

  • Nanjing Children's Hospital

Investigators

  • Study Director: Weibing Tang, Dr, Children's Hospital of Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weibing Tang, Director, Nanjing Children's Hospital
ClinicalTrials.gov Identifier:
NCT05716230
Other Study ID Numbers:
  • NanjingCH0109
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Weibing Tang, Director, Nanjing Children's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023