Are enemas indicated for treatment of children with solitair encopresis?

ISRCTN ISRCTN28937219
DOI https://doi.org/10.1186/ISRCTN28937219
Secondary identifying numbers NTR65
Submission date
12/09/2005
Registration date
12/09/2005
Last edited
07/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M A Benninga
Scientific

Academic Medical Centre
Pediatric Department
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands

+31 (0)20 566 3053
m.a.benninga@amc.nl

Study information

Study designRandomised open label active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleAre enemas indicated for treatment of children with solitair encopresis?
Study objectivesThe 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.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedFunctional non-retentive faecal soiling
InterventionGroup 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.
Intervention typeOther
Primary outcome measure1. 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 measuresTolerance of enemas: abdominal pain, painful defecation, nausea, vomiting, flatulency.
Overall study start date01/03/2002
Completion date01/03/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit8 Years
Upper age limit17 Years
SexBoth
Target number of participants78
Total final enrolment71
Key inclusion criteria1. 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
Key exclusion criteria1. Gastro-intestinal surgery
2. Anorectal anomaly
3. Mental retardation
4. Constipation
Date of first enrolment01/03/2002
Date of final enrolment01/03/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Funders

Funder type

Hospital/treatment centre

Academic Medical Centre (AMC) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2013 07/01/2021 Yes No

Editorial Notes

07/01/2021: Publication reference and total final enrolment added.

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