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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22780

Enrollment

100

Registered

2005-06-21

Start date

2003-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1: weekly enemas + standardtreatment

Groep 2: standardtreatment with oral laxantia (movicolon).

Eligibility

Inclusion criteria

Inclusion criteria: Rome II-criteria for constipation, age 8-18 year.

Exclusion criteria

Exclusion criteria: 1. Hirschsprung's disease; 2. gastro-intestinal surgery; 3. anorectal anomaly; 4. metabolism disorders; 5. mental retardation.

Design outcomes

Primary

Measure	Time frame
Defecation frequency, soiling/encopresis frequency, stool consistency; use of laxatives. 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

Measure	Time frame
Rectal compliance and sensation at t=0 en t=52 weeks; A barostat is performed in all children pre-treatment and after 1 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.	—

Contacts

Public ContactMarc A. Benninga

Kinderarts MDL, AMC, H7-248 P.O. Box 22660

m.a.benninga@amc.nl+31 (0)20 5663053 / +31 (0)20 5666297

Outcome results