No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
N/A
Study objective
1. Early intervention with oral AND rectal laxatives will lead to a higher success percentage compared to standard treatment in constipated children;
2. Long lasting fecal stasis leads to abnormal rectal functions (compliance and sensation);
3. Early frequent rectal laxatives prevent irreversible damage to rectal function.
Study design
N/A
Intervention
Group 1: weekly enemas + standardtreatment;
Groep 2: standardtreatment with oral laxantia (movicolon).
P.O. Box 22660
Marc A. Benninga
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663053 / +31 (0)20 5666297
m.a.benninga@amc.nl
P.O. Box 22660
Marc A. Benninga
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663053 / +31 (0)20 5666297
m.a.benninga@amc.nl
Inclusion criteria
Rome II-criteria for constipation, age 8-18 year.
Exclusion criteria
1. Hirschsprung's disease;
2. gastro-intestinal surgery;
3. anorectal anomaly;
4. metabolism disorders;
5. mental retardation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL18 |
| NTR-old | NTR36 |
| Other | : N/A |
| ISRCTN | ISRCTN99089299 |