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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05716230
Enrollment
150
Registered
2023-02-08
Start date
2022-11-20
Completion date
2023-02-28
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Dysfunction

Keywords

anorectal malformation, Bowel function, risk factors

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.

Interventions

OTHERbowel 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.

Sponsors

Nanjing Children's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Anorectal malformation \>4 years old

Exclusion criteria

Down syndrome patients \<4 years

Design outcomes

Primary

MeasureTime frameDescription
bowel function score in partipants with ARMthrough study completion, an average of 6 yearapproved by Rintala in 1995, and patients with a score ≥ 17 were considered to have normal bowel habits

Secondary

MeasureTime frameDescription
Sacral ratio in partipants with ARMthrough study completion, an average of 6 yeartest by X ray

Other

MeasureTime frameDescription
Number of partipants performed with every surgical methodthrough study completion, an average of 6 yearPosterior sagittal approach to anoplasty or Anterior sagittal approach to anoplasty or Laparoscopic assisted anoplasty
Number of partipants with every type of ARMthrough study completion, an average of 6 yearconfirmed in surgery
Number of partipants with reoperationthrough study completion, an average of 6 yearre-anoplasty
Number of partipants with abnormal spinal cordthrough study completion, an average of 6 yeartethered cord or other
age at surgery of partipants with ARMthrough study completion, an average of 6 yearage at surger

Countries

China

Contacts

Primary ContactChanggui Lu, Dr
luchanggui1984@163.com13770848448

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026