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Are enemas indicated for treatment of children with solitair encopresis?
ISRCTN ISRCTN28937219
DOI 10.1186/ISRCTN28937219
ClinicalTrials.gov identifier
EudraCT number
Public title Are enemas indicated for treatment of children with solitair encopresis?
Scientific title
Acronym N/A
Serial number at source NTR65
Study hypothesis The 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.
Lay summary
Ethics approval Ethics approval received from the local medical ethics committee
Study design Randomised open label active controlled parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Functional non-retentive faecal soiling
Participants - inclusion criteria 1. Aged 8 to 17 years
2. Functional Non-Retentive Faecal Soiling (FNRFS) criteria:
2.1. defaecation frequency three times a week
2.2. encopresis frequency more than once a week
2.3. no faecal impaction with physical examination
Participants - exclusion criteria 1. Gastro-intestinal surgery
2. Anorectal anomaly
3. Mental retardation
4. Constipation
Anticipated start date 01/03/2002
Anticipated end date 01/03/2005
Status of trial Completed
Patient information material
Target number of participants 78
Interventions Group one: enemas following a schedule during three months
Group two: no laxantia, but education and toilet training

The anticipated end date of this trial was increased to the 31st December 2006.
Primary outcome measure(s) 1. 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 = one week, two weeks, four weeks, six 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 outcome measure(s) Tolerance of enemas: abdominal pain, painful defecation, nausea, vomiting, flatulency.
Sources of funding Academic Medical Centre (AMC) (Netherlands)
Trial website
Publications
Contact name Dr  M A  Benninga
  Address Academic Medical Centre
Pediatric Department
P.O. Box 22660
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Tel +31 (0)20 566 3053
  Email m.a.benninga@amc.nl
Sponsor Academic Medical Centre (AMC) (Netherlands)
  Address Pediatric Department
Meibergdreef 9
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Sponsor website: http://www.amc.uva.nl/
Date applied 12/09/2005
Last edited 01/09/2009
Date ISRCTN assigned 12/09/2005
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