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Clinical Trials/NCT02212054
NCT02212054
Recruiting
Not Applicable

A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Children With Hirschsprung Allied Disease

Tongji Hospital1 site in 1 country50 target enrollmentMay 1, 2020
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ConditionsComplications of TreatmentComplication of Surgical ProcedureMegacolon, Not Hirschsprung

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complications of Treatment
Sponsor
Tongji Hospital
Enrollment
50
Locations
1
Primary Endpoint
the change of defecation frequency
Status
Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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

Detailed Description

The present study was designed to compare the efficacy of conservative treatment,such as anal dilatation, colonic lavage and so on, to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
December 1, 2025
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Feng Jiexiong

Chief of pediatric surgery department

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

  • •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,
  • •28(5): p. 689-96

Exclusion Criteria

  • •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,
  • •28(5): p. 689-96

Outcomes

Primary Outcomes

the change of defecation frequency

Time Frame: 6~12 months

the changes of defecation frequency at 6\~12 months after treatment

Secondary Outcomes

  • complications(6~12 months)
  • stool pattern(6~12 months)
  • controlling stool ability(6~12 months)

Study Sites (1)

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