A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Children With Hirschsprung Allied Disease
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Tongji Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- the change of defecation frequency
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
- •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,
- •28(5): p. 689-96
Arms & Interventions
conservative & operative treatment
anal dilation; colon lavage; probiotics
Intervention: conservative (Behavioral)
operative treatment
one stage pull- through radical colectomy
Intervention: operative (Procedure)
Outcomes
Primary Outcomes
the change of defecation frequency
Time Frame: 6~12 months
the changes of defecation frequency at 6\~12 months after treatment
Secondary Outcomes
- complications(6~12 months)
- stool pattern(6~12 months)
- controlling stool ability(6~12 months)
Investigators
Feng Jiexiong
Chief of pediatric surgery department
Tongji Hospital