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

NCT ID: NCT05655845

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-20
• Study Completion Date: 2023-08-30

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.

Detailed Description

Hirschsprung disease (HD) is a distinctive congenital disease with the absence of ganglion cells in the distal intestine leads to distal bowel obstruction and defecation disorders. HD is a rare disease, with a reported incidence of 1:5,000, requiring proper surgical treatment for the maintenance of normal or near-normal bowel movement.To date, there is insufficient evidence to recommend a preferred or superior method for the surgical repair, and a pull-through with or without laparoscopy was the most common procedure for correction of HD,which may have faster recovery and less rate of complication compared to other surgical approaches.The short or long-term outcomes of HD have been deeply assessed in the past few years,and bowel dysfunction,consist of soling, incontinence and constipation, had been proven as the most common complication,which may be a ongoing issue and lead to social problems,which should not be ignored. Otherwise,there were many reports proved that poor bowel function in preschool and early childhood may lead to social problems and depression in adolescence or adult.Many factors may lead to bowel dysfunction in HD, including length of aganglionic segement,anastomotic leakage or redo-PT,unsuitable timing of surgery,etc.Thus,the present study was designed to seek the risk factors for bowel dysfunction of HD,which is meaningful to maintain or improve the bowel function in preschool and early childhood.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

bowel function score(BFS) questionnaire survey

Intervention Type: 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. .

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.

bowel function score(BFS) questionnaire survey

Intervention Type: 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. .

Interventions

bowel function score(BFS) questionnaire survey

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. .

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Clinical dignosis with Hirschsprung disease

2. completed the toilet training

Exclusion Criteria

1. redo-pull-through,

2. Down syndrome or other co-morbidities that impaired functional outcomes

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weibing Tang

OTHER

Sponsor Role: lead

Responsible Party

Weibing Tang

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Weibing Tang, Dr

Role: STUDY_DIRECTOR

Children's Hospital of Nanjing Medical University

Locations

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Changgui Lu, Dr

Role: CONTACT

luchanggui1984@163.com

13770848448

Facility Contacts

Changgui Lu, Dr

Role: primary

luchanggui1984@163.com

13770848448

References

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.

Reference Type: DERIVED

PMID: 40634926 (View on PubMed)

Other Identifiers

NanjingCH1129

Identifier Type: -

Identifier Source: org_study_id