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

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.

Study Overview

• Status: Recruiting
• Conditions: Bowel Dysfunction
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Children's Hospital of Nanjing Medical University
      • Contact: Changgui Lu; Phone Number: 13770848448; Email: luchanggui1984@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

Anorectal malformation >4 years old

Exclusion Criteria:

Down syndrome patients <4 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sacral ratio in partipants with ARM	test by X ray	through study completion, an average of 6 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of partipants with every type of ARM	confirmed in surgery	through study completion, an average of 6 year
age at surgery of partipants with ARM	age at surger	through study completion, an average of 6 year
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
Number of partipants with abnormal spinal cord	tethered cord or other	through study completion, an average of 6 year
Number of partipants with reoperation	re-anoplasty	through study completion, an average of 6 year

Collaborators and Investigators

• Sponsor: Nanjing Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2022
• Primary Completion (ACTUAL): January 29, 2023
• Study Completion (ANTICIPATED): February 28, 2023

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 28, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 28, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: risk factors; Bowel function; anorectal malformation
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Digestive System Abnormalities; Congenital Abnormalities; Intestinal Diseases; Anorectal Malformations
• Other Study ID Numbers: NanjingCH0109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No