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
Protocol serial number	NTR36
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Academic Medical Centre (AMC) (The Netherlands)

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

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	1. 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) studied	Constipation
Intervention	Group 1: weekly enemas and standard treatment Group 2: standard treatment with oral laxative (movicolon)
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Movicolon
Primary outcome measure(s)	1. 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.
Key secondary outcome measure(s)	Rectal 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.
Completion date	01/12/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. Rome II criteria for constipation 2. Aged 8 - 18 years
Key exclusion criteria	1. Hirschsprung's disease 2. Gastrointestinal surgery 3. Anorectal anomaly 4. Metabolism disorders 5. Mental retardation
Date of first enrolment	01/01/2003
Date of final enrolment	01/12/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Meibergdreef 9

Amsterdam
1105 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan