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

Bowel Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716230
• Other study ID #: NanjingCH0109
• Status: Recruiting
• Start date: November 20, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: January 2023
• Source: Nanjing Children's Hospital
• Contact: Changgui Lu, Dr
• Phone: 13770848448
• Email: luchanggui1984[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 28, 2023
• Est. primary completion date: January 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

Inclusion Criteria:

Anorectal malformation >4 years old Exclusion Criteria: Down syndrome patients <4 years

Related Conditions & MeSH terms

• Anorectal Malformations
• Bowel Dysfunction
• Congenital Abnormalities
• Intestinal Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Children's Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of partipants with every type of ARM	confirmed in surgery	through study completion, an average of 6 year
Other	age at surgery of partipants with ARM	age at surger	through study completion, an average of 6 year
Other	Number of partipants performed with every surgical method	Posterior sagittal approach to anoplasty or Anterior sagittal approach to anoplasty or Laparoscopic assisted anoplasty	through study completion, an average of 6 year
Other	Number of partipants with abnormal spinal cord	tethered cord or other	through study completion, an average of 6 year
Other	Number of partipants with reoperation	re-anoplasty	through study completion, an average of 6 year
Primary	bowel function score in partipants with ARM	approved by Rintala in 1995, and patients with a score = 17 were considered to have normal bowel habits	through study completion, an average of 6 year
Secondary	Sacral ratio in partipants with ARM	test by X ray	through study completion, an average of 6 year