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


- candidate number0
- NTR NumberNTR36
- ISRCTNISRCTN99089299
- Date ISRCTN created5-aug-2005
- date ISRCTN requested18-jul-2005
- Date Registered NTR21-jun-2005
- Secondary IDsN/A 
- Public TitleThe effect of additional use of enemas versus the standard treatment of chronic constipation in children.
- Scientific TitleThe effect of additional use of enemas versus the standard treatment of chronic constipation in children.
- ACRONYMN/A
- hypothesis1. 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.
- Healt Condition(s) or Problem(s) studiedConstipation
- Inclusion criteriaRome II-criteria for constipation, age 8-18 year.
- Exclusion criteria1. Hirschsprung's disease;
2. gastro-intestinal surgery;
3. anorectal anomaly;
4. metabolism disorders;
5. mental retardation.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2003
- planned closingdate1-dec-2005
- Target number of participants100
- InterventionsGroup 1: weekly enemas + standardtreatment;
Groep 2: standardtreatment with oral laxantia (movicolon).
- Primary outcomeDefecation 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 outcomeRectal 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.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. Marc A. Benninga
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Marc A. Benninga
- Sponsor/Initiator Academic Medical Center (AMC), Department of Pediatric
- Funding
(Source(s) of Monetary or Material Support)
Fonds kindermotiliteit
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD11-jul-2005 - 17-sep-2008


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