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

Sponsor
Weibing Tang (Other)
Overall Status
Recruiting
CT.gov ID
NCT05655845
Collaborator
(none)
300
1
10.3
29.1

Study Details

Study Description

Brief Summary

Bowel dysfunction has been proven as the most common complication after pull-through(PT) of Hirschsprung disease(HD) at preschool and early childhood age,which may persist to adulthood and lead to social problems.The reason of bowel dysfunction is complicated and the risk factors were not defined.The present study was designed to seek the risk factors for bowel dysfunction of HD at preschool and early childhood age.

Condition or Disease Intervention/Treatment Phase
  • Other: bowel function score(BFS) questionnaire survey

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 transanal endorectal pull-through or laparoscopic-assisted transanal endorectal pull-through 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 outcomes of HD has been widely evaluated in the past decades,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. A lot of studies has been designed to explore the trend toward to normal bowel habits from preschool and early childhood age to adolescence or adult,however,no identified improvement of bowel habits was completely confirmed.In contrast,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.The reasons of poor dysfunction of HD in preschool and early childhood were complicated and undefined,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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Bowel Function and Risk Factors for Bowel Dysfunction at Preschool and Early Childhood Age in Children With Hirschsprung Disease
Actual Study Start Date :
Aug 20, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

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. .

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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)

  3. 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].

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Nanjing Medical University Nanjing Jiangsu China 210008

Sponsors and Collaborators

  • Weibing Tang

Investigators

  • Study Director: Weibing Tang, Dr, Children's Hospital of Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weibing Tang, Clinical Professor, Nanjing Children's Hospital
ClinicalTrials.gov Identifier:
NCT05655845
Other Study ID Numbers:
  • NanjingCH1129
First Posted:
Dec 19, 2022
Last Update Posted:
Dec 19, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Weibing Tang, Clinical Professor, Nanjing Children's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 19, 2022