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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05655845
• Other study ID #: NanjingCH1129
• Status: Recruiting
• Start date: August 20, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: August 2023
• Source: Nanjing Children's Hospital
• Contact: Changgui Lu, Dr
• Phone: 13770848448
• Email: luchanggui1984[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bowel Dysfunction
• Constipation
• Gastrointestinal Diseases
• Hirschsprung Disease
• Incontinence
• Intestinal Diseases
• Risk Factor

Intervention

Other:
• 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. .

Locations

Country	Name	City	State
China	Children's Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Weibing Tang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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 [grade?]; and severe HAEC [grade ?].	through study completion, an average of 5 year