Clinical trial NCT05716230: Bowel Function and Associated Risk Factors for Bowel Dysfunciton in Patients With Anorectal Malformation
Official title: Bowel Function and Associated Risk Factors for Bowel Dysfunciton in Preschool and Early Childhood in Patients With Anorectal Malformation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bowel Dysfunction
Keywords: anorectal malformation
Bowel function
risk factors
Lead sponsor: Nanjing Children's Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ARM who were performed with surgery.The follow-up age was more than 4 years old.

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.

Eligibility criteria: Inclusion Criteria:

Anorectal malformation \>4 years old

Exclusion Criteria:

Down syndrome patients \<4 years

Primary outcomes:
measure: bowel function score in partipants with ARM
timeFrame: through study completion, an average of 6 year
Secondary outcomes:
measure: Sacral ratio in partipants with ARM
timeFrame: through study completion, an average of 6 year
Other outcomes:
measure: Number of partipants with every type of ARM
timeFrame: through study completion, an average of 6 year
measure: age at surgery of partipants with ARM
timeFrame: through study completion, an average of 6 year
measure: Number of partipants performed with every surgical method
timeFrame: through study completion, an average of 6 year
measure: Number of partipants with abnormal spinal cord
timeFrame: through study completion, an average of 6 year
measure: Number of partipants with reoperation
timeFrame: through study completion, an average of 6 year
Locations:
city: Nanjing
country: China
facility: Children's Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Children's Hospital of Nanjing Medical University
name: Weibing Tang, Dr
role: STUDY_DIRECTOR
References: