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
Scientific
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)205663053 |
|---|---|
| m.a.benninga@amc.nl |
Study information
| Study design | Randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Movicolon |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/01/2003 |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
University/education
University/education
Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
