The effect of additional use of enemas versus the standard treatment of chronic constipation in childre
Completed
- Conditions
- ConstipationDigestive System
- Registration Number
- ISRCTN99089299
- Lead Sponsor
- Academic Medical Centre (AMC) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1. Rome II criteria for constipation
2. Aged 8 - 18 years
Exclusion Criteria
1. Hirschsprung's disease
2. Gastrointestinal surgery
3. Anorectal anomaly
4. Metabolism disorders
5. Mental retardation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Defecation frequency<br>2. Soiling/encopresis frequency<br>3. Stool consistency<br>4. Use of laxatives<br><br>Patients will visit our out-patient visits for follow-up at several fixed moments: intake and t = 2 weeks, 4 weeks, 6 weeks, 12 weeks, 26 weeks, 39 weeks and 52 weeks. During this study, all patients will record in a specific diary on primary outcome measurements.
- Secondary Outcome Measures
Name Time Method Rectal compliance and sensation at t = 0 and t = 52 weeks. A barostat is performed in all children pre-treatment and after one year of treatment and rectal functions are determined (rectal compliance and sensation). The results of t = 0 and t = 52 weeks are compared to assess possible differences in rectal function.