A Trial on Treatments of Hirschsprung Allied Disease

Study Overview
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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 children with Hirschsprung allied disease

Detailed Description
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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

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

Conditions
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Complications of Treatment, Complication of Surgical Procedure, Megacolon, Not Hirschsprung

Intervention / Treatment
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* Behavioral: conservative
* Procedure: operative


Participation Criteria
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Eligibility Criteria
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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, 2013. 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, 2013. 28(5): p. 689-96

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conservative & operative treatment<br>anal dilation; colon lavage; probiotics | Behavioral: conservative<br>* anal dilatation; colonic lavage; oral probiotic<br>|
| Active Comparator: operative treatment<br>one stage pull- through radical colectomy | Procedure: operative<br>* one stage pull through radical colectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of defecation frequency | the changes of defecation frequency at 6 12 months after treatment | 6 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stool pattern | stool pattern as hard stool or loose stool | 6 12 months | 
| controlling stool ability | whether patients' controlling stool ability is better or not after treatment | 6 12 months | 
| complications | complications were suffered by patients or not | 6 12 months |