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A Trial on Conservative Treatment for Infants' Hirschsprung Disease

NCT ID: NCT01985646

Last Updated: 2013-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Brief Summary

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The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in infants with short or normal-segment Hirschsprung disease.

Detailed Description

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Conditions

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Hirschsprung Disease

Keywords

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Hirschsprung disease conservative treatment surgery treatment infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgery treatment

one stage pull through left-colectomy

Group Type EXPERIMENTAL

surgery treatment

Intervention Type PROCEDURE

one staged pull-through left-colectomy

conservative treatment

anal dilation, colonic lavage, oral probiotic

Group Type EXPERIMENTAL

anal dilation

Intervention Type BEHAVIORAL

anal dilation

colonic lavage

Intervention Type BEHAVIORAL

colonic lavage

oral probiotic

Intervention Type DRUG

oral probiotic

Interventions

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surgery treatment

one staged pull-through left-colectomy

Intervention Type PROCEDURE

anal dilation

anal dilation

Intervention Type BEHAVIORAL

colonic lavage

colonic lavage

Intervention Type BEHAVIORAL

oral probiotic

oral probiotic

Intervention Type DRUG

Eligibility 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
Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiexiong Feng

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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20090302

Identifier Type: OTHER

Identifier Source: secondary_id

001

Identifier Type: -

Identifier Source: org_study_id