Clinical trial NCT05655845: Risk Factors for Bowel Dysfunction at Preschool and Early Childhood Age in Children With Hirschsprung Disease
Official title: Bowel Function and Risk Factors for Bowel Dysfunction at Preschool and Early Childhood Age in Children With Hirschsprung Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bowel Dysfunction
Hirschsprung Disease
Risk Factor
Incontinence
Constipation
Keywords: Hirschsprung Disease
Bowel function
associated factors
Lead sponsor: Nanjing Children's Hospital
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: bowel function score
timeFrame: through study completion, an average of 5 year
measure: Clavien-Dindo classifification of surgical complications
timeFrame: through study completion, an average of 5 year
measure: Hirschsprung disease associated enterocolitis(HAEC)
timeFrame: through study completion, an average of 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Children's Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Children's Hospital of Nanjing Medical University
name: Weibing Tang, Dr
role: STUDY_DIRECTOR
References: