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

Recruiting

• Conditions: Bowel Dysfunction; Hirschsprung Disease; Risk Factor; Incontinence; Constipation
• Interventions: Other: bowel function score(BFS) questionnaire survey

• Registration Number: NCT05655845
• Lead Sponsor: Weibing Tang

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.

Study Timeline

• Study Start: 2022-08-20
• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2022-12-09
• Study First Posted: 2022-12-19
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-23
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
near-normal group	bowel function score(BFS) 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.
Dysfunction group	bowel function score(BFS) 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 bowel dysfunction.

Primary Outcome Measures

Name	Time	Method
Hirschsprung disease associated enterocolitis(HAEC)	through study completion, an average of 5 year	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 \[grade Ⅲ\].
bowel function score	through study completion, an average of 5 year	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.
Clavien-Dindo classifification of surgical complications	through study completion, an average of 5 year	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)

Trial Locations

Locations (1)

Children's Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China