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

NCT05716230 | Unknown DMC

• 1 other identifier: NanjingCH0109
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Dysfunction

Keywords

anorectal malformation; Bowel function; risk factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sacral ratio in partipants with ARM

  through study completion, an average of 6 year

Other Outcomes (5)

• Number of partipants with every type of ARM

  through study completion, an average of 6 year

• age at surgery of partipants with ARM

  through study completion, an average of 6 year

• Number of partipants performed with every surgical method

  through study completion, an average of 6 year

Interventions

bowel function score questionnaire survey OTHER

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.

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Anorectal malformation \>4 years old

You may not qualify if:

• Down syndrome patients \<4 years

Sponsors & Collaborators

• Nanjing Children's Hospital: lead

Study Sites (1)

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37935997 DERIVED

MeSH Terms

Conditions

Intestinal Diseases; Anorectal Malformations

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Weibing Tang, Dr

  Children's Hospital of Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Changgui Lu, Dr

CONTACT

13770848448; luchanggui1984@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: February 8, 2023
• Study Start: November 20, 2022
• Primary Completion: January 29, 2023
• Study Completion: February 28, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-01

Locations

CN (1)