A Trial on Treatments of Hirschsprung Allied Disease
A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Children With Hirschsprung Allied Disease
1 other identifier
interventional
50
1 country
1
Brief Summary
The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2014
CompletedFirst Posted
Study publicly available on registry
August 8, 2014
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMarch 11, 2020
March 1, 2020
5 years
August 6, 2014
March 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
the change of defecation frequency
the changes of defecation frequency at 6\~12 months after treatment
6~12 months
Secondary Outcomes (3)
stool pattern
6~12 months
controlling stool ability
6~12 months
complications
6~12 months
Study Arms (2)
conservative & operative treatment
EXPERIMENTALanal dilation; colon lavage; probiotics
operative treatment
ACTIVE COMPARATORone stage pull- through radical colectomy
Interventions
anal dilatation; colonic lavage; oral probiotic
Eligibility Criteria
You may qualify if:
- hard or firm stools for twice or less per week
- a predicting score of less than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis, 2013. 28(5): p. 689-96
You may not qualify if:
- functional constipation
- a predicting score of more than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis, 2013. 28(5): p. 689-96
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Study Sites (1)
Department of Pediatric Surgery
Wuhan, Hubei, 430000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qi T Zhu, PhD
department of pediatric surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of pediatric surgery department
Study Record Dates
First Submitted
August 6, 2014
First Posted
August 8, 2014
Study Start
May 1, 2020
Primary Completion
May 1, 2025
Study Completion
December 1, 2025
Last Updated
March 11, 2020
Record last verified: 2020-03