NCT01985646
Completed
Early Phase 1
A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Normal and Short-segment Hirschsprung Disease for Infants
ConditionsHirschsprung Disease
Drugsoral probiotic
Overview
- Phase
- Early Phase 1
- Intervention
- surgery treatment
- Conditions
- Hirschsprung Disease
- Sponsor
- Tongji Hospital
- Enrollment
- 48
- Primary Endpoint
- the change of defecation frequence
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Jiexiong Feng
professor
Tongji Hospital
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
Arms & Interventions
surgery treatment
one stage pull through left-colectomy
Intervention: surgery treatment
conservative treatment
anal dilation, colonic lavage, oral probiotic
Intervention: anal dilation
conservative treatment
anal dilation, colonic lavage, oral probiotic
Intervention: colonic lavage
conservative treatment
anal dilation, colonic lavage, oral probiotic
Intervention: oral probiotic
Outcomes
Primary Outcomes
the change of defecation frequence
Time Frame: 6~12 months
the changes of defecation frequence at 6\~12 months after treatment
Secondary Outcomes
- stool pattern(6~12 months)
- controlling defecation ability(6~12 months)
- complications(6~12 months)
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