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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01985646 |
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Date of registration:
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31/10/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Trial on Conservative Treatment for Infants' Hirschsprung Disease
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Scientific title:
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A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Normal and Short-segment Hirschsprung Disease for Infants |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01985646 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 0
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Hard or firm stools for twice or less per week
- Age were from newborn to 3 months
- Histochemical acetylcholinesterase reaction (AChE) in rectal mucosa was positive
- The narrowed distal bowel on barium enema was characterized as normal or
short-segment Hirschsprung disease with a 24h barium retention
Exclusion Criteria:
- Children >3months of age
- Patients presented severe inflammation or malnutrition, unconsciousness, and symptoms
of a ruptured hollow viscus
- Barium enema showed long-segment or total colonic aganglionic bowel
Age minimum:
N/A
Age maximum:
3 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hirschsprung Disease
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Intervention(s)
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Behavioral: colonic lavage
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Drug: oral probiotic
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Behavioral: anal dilation
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Procedure: surgery treatment
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Primary Outcome(s)
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the change of defecation frequence
[Time Frame: 6~12 months]
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Secondary Outcome(s)
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stool pattern
[Time Frame: 6~12 months]
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controlling defecation ability
[Time Frame: 6~12 months]
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complications
[Time Frame: 6~12 months]
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Secondary ID(s)
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20090302
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001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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