search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Are enemas indicated for treatment of children with solitair encopresis?


- candidate number0
- NTR NumberNTR65
- ISRCTNISRCTN28937219
- Date ISRCTN created12-sep-2005
- date ISRCTN requested18-jul-2005
- Date Registered NTR21-jun-2005
- Secondary IDsN/A 
- Public TitleAre enemas indicated for treatment of children with solitair encopresis?
- Scientific TitleAre enemas indicated for treatment of children with solitair encopresis?
- ACRONYMN/A
- hypothesisThe use of enemas will result in a empty rectum and no more soiling or encopresis. In this period these children will experience and get used to a clean feeling and the advantages. This might lead to a better motivation for treatment of solitair encopresis.
- Healt Condition(s) or Problem(s) studiedFunctional non-retentive faecal soiling
- Inclusion criteriaAge 8-17 yrs,
FNRFS criteria: def. Frequency. 3/wk, encopresis frequency >1/wk, no faecal impaction with physical examination.
- Exclusion criteria1. Gastro-intestinal surgery,
2. anorectal anomaly,
3. mental retardation,
4. constipation.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2002
- planned closingdate31-dec-2006
- Target number of participants78
- InterventionsGroup 1: enemas following a schedule during 3 months;
Group 2: no laxantia, but education and toilettraining.
- Primary outcome1. Defecation frequency,
2. soiling/encopresis frequency,
3. stool consistency.
Patients will visit our out-patient visits for follow-up at several fixed moments: intake and t= 1 week, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 6 months, 12 months; during this study, all patients will record in a specific diary on primary and secondary outcome measurements.
- Secondary outcomeTolerance of enemas: abdominal pain, painful defecation, nausea, vomiting, flatulency.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- 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)
- RECORD4-aug-2005 - 14-sep-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl
  • Dit zijn de gegevens waarmee uw trial is aangemeld en geregistreerd in het Nederlands Trial Register