Back to resultsA Trial on Conservative Treatment for Infants' Hirschsprung Disease
Primary Purpose
Hirschsprung Disease
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
surgery treatment
anal dilation
colonic lavage
oral probiotic
Sponsored by
About this trial
This is an interventional treatment trial for Hirschsprung Disease focused on measuring Hirschsprung disease, conservative treatment, surgery treatment, infants
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
surgery treatment
conservative treatment
Arm Description
one stage pull through left-colectomy
anal dilation, colonic lavage, oral probiotic
Outcomes
Primary Outcome Measures
the change of defecation frequence
the changes of defecation frequence at 6~12 months after treatment
Secondary Outcome Measures
stool pattern
stool pattern as Forming soft stool or Loose stool
controlling defecation ability
whether patients' controlling of defecation be better or not after treatment
complications
complications were suffered by patients or not, such as enterolitis, anastomotic stenosis etc.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01985646
Brief Title
A Trial on Conservative Treatment for Infants' Hirschsprung Disease
Official Title
A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Normal and Short-segment Hirschsprung Disease for Infants
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hirschsprung Disease
Keywords
Hirschsprung disease, conservative treatment, surgery treatment, infants
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surgery treatment
Arm Type
Experimental
Arm Description
one stage pull through left-colectomy
Arm Title
conservative treatment
Arm Type
Experimental
Arm Description
anal dilation, colonic lavage, oral probiotic
Intervention Type
Procedure
Intervention Name(s)
surgery treatment
Intervention Description
one staged pull-through left-colectomy
Intervention Type
Behavioral
Intervention Name(s)
anal dilation
Intervention Description
anal dilation
Intervention Type
Behavioral
Intervention Name(s)
colonic lavage
Intervention Description
colonic lavage
Intervention Type
Drug
Intervention Name(s)
oral probiotic
Intervention Description
oral probiotic
Primary Outcome Measure Information:
Title
the change of defecation frequence
Description
the changes of defecation frequence at 6~12 months after treatment
Time Frame
6~12 months
Secondary Outcome Measure Information:
Title
stool pattern
Description
stool pattern as Forming soft stool or Loose stool
Time Frame
6~12 months
Title
controlling defecation ability
Description
whether patients' controlling of defecation be better or not after treatment
Time Frame
6~12 months
Title
complications
Description
complications were suffered by patients or not, such as enterolitis, anastomotic stenosis etc.
Time Frame
6~12 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
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A Trial on Conservative Treatment for Infants' Hirschsprung Disease
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