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

ISRCTN ISRCTN99089299
DOI https://doi.org/10.1186/ISRCTN99089299
Secondary identifying numbers NTR36
Submission date
04/08/2005
Registration date
04/08/2005
Last edited
11/06/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M.A. Benninga
Scientific

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone +31 (0)205663053
Email m.a.benninga@amc.nl

Study information

Study designRandomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectives1. 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
Ethics approval(s)Ethics approval received from the local ethics committee
Health condition(s) or problem(s) studiedConstipation
InterventionGroup 1: weekly enemas and standard treatment
Group 2: standard treatment with oral laxative (movicolon)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Movicolon
Primary outcome measure1. Defecation frequency
2. Soiling/encopresis frequency
3. Stool consistency
4. 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 measuresRectal compliance and sensation at t = 0 and t = 52 weeks. A barostat is performed in all children pre-treatment and after one 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.
Overall study start date01/01/2003
Completion date01/12/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit8 Years
Upper age limit18 Years
SexBoth
Target number of participants100
Key inclusion criteria1. Rome II criteria for constipation
2. Aged 8 - 18 years
Key exclusion criteria1. Hirschsprung's disease
2. Gastrointestinal surgery
3. Anorectal anomaly
4. Metabolism disorders
5. Mental retardation
Date of first enrolment01/01/2003
Date of final enrolment01/12/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
University/education

Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands

Website http://www.amc.uva.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Centre (AMC) (The 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