The effect of additional use of enemas versus the standard treatment of chronic constipation in childre

Completed

• Conditions: Constipation; Digestive System

• Registration Number: ISRCTN99089299
• Lead Sponsor: Academic Medical Centre (AMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-04
• Last Update Posted: 13 January 2015

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.