Risk Factors for Bowel Dysfunction at Preschool and Early Childhood Age in Children With Hirschsprung Disease

NCT05655845 | Unknown

• 1 other identifier: NanjingCH1129
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Bowel dysfunction has been proven as the most common complication after pull-through(PT) of Hirschsprung disease(HD) ，which may persist to adulthood and lead to social problems.The reason of bowel dysfunction is complicated and the risk factors were not defined.

Conditions

Bowel Dysfunction; Hirschsprung Disease; Risk Factor; Incontinence; Constipation

Keywords

Hirschsprung Disease; Bowel function; associated factors

Outcome Measures

Primary Outcomes (3)

• bowel function score

  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 ability to hold back defecation,feels/reports the urge to defecate,frequency of defecation,soiling,accidents,constipation.

  through study completion, an average of 5 year

• Clavien-Dindo classifification of surgical complications

  Clavien-Dindo is an objective grading system, which is used for grading postoperative complications in a reproduceable manner.It consists of five grades ranging from any deviation from a normal postoperative course (Grade I) to death (Grade V)

  through study completion, an average of 5 year

• Hirschsprung disease associated enterocolitis(HAEC)

  The guidelines for the diagnosis and management of HAEC were defined by the American Pediatric Surgical Association in 2017. There are three types of HAEC defined by severity: possible HAEC \[grade I\]; definite HAEC \[gradeⅡ\]; and severe HAEC \[grade Ⅲ\].

  through study completion, an average of 5 year

Study Arms (2)

Dysfunction group

Bowel function score(BFS,total 20 points) was approved by Rintala in 1995 and patients with a score \< 17 were considered to have bowel dysfunction.

Other: bowel function score(BFS) questionnaire survey

near-normal group

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.

Other: bowel function score(BFS) questionnaire survey

Interventions

bowel function score(BFS) questionnaire survey OTHER

A cross-sectional bowel function score(BFS) questionnaire survey was conducted in patients with HD who underwent PTs between January 2014 and December 2019 at Children's Hospital of Nanjing Medical University.Patients consented to the survey were asked to complete the questionnaire,and were divided into two groups: dysfunction group(BFS\<17 ); and normal group (BFS\>=17 ). The operative age, birth weight, premature delivery status, operative weight, aganglionic segment, single or stage PT, surgical approach(laparotomy or laparoscopy), post-operative Hirschsprung-associated enterocolitis (HAEC),and immediate complications were recorded and compared between two groups。Both univariate and multivariate regression analysis were used to seek the risk factors of bowel dysfunction after PTs in HD. .

Dysfunction group; near-normal group

Eligibility Criteria

• Age: 3 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 HD who underwent PTs between January 2014 and December 2019 at Children's Hospital of Nanjing Medical University.

You may qualify if:

• Clinical dignosis with Hirschsprung disease
• completed the toilet training

You may not qualify if:

• redo-pull-through,
• Down syndrome or other co-morbidities that impaired functional outcomes

Sponsors & Collaborators

• Weibing Tang: lead

Study Sites (1)

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (1)

• Pan S, Li W, Shi C, Tang W, Lu C. Features of defecation dysfunction among patients with Hirschsprung disease in early childhood. BMC Gastroenterol. 2025 Jul 9;25(1):510. doi: 10.1186/s12876-025-04106-4.

  PMID: 40634926 DERIVED

MeSH Terms

Conditions

Intestinal Diseases; Hirschsprung Disease; Constipation

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Digestive System Abnormalities; Megacolon; Colonic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 19, 2022
• Study Start: August 20, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)