Are enemas indicated for treatment of children with solitair encopresis?
ISRCTN | ISRCTN28937219 |
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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
Scientific
Academic Medical Centre
Pediatric Department
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
Phone | +31 (0)20 566 3053 |
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m.a.benninga@amc.nl |
Study information
Study design | Randomised open label active controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Are enemas indicated for treatment of children with solitair encopresis? |
Study objectives | 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. |
Ethics approval(s) | Ethics approval received from the local medical ethics committee |
Health condition(s) or problem(s) studied | Functional non-retentive faecal soiling |
Intervention | 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. |
Intervention type | Other |
Primary outcome measure | 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 measures | Tolerance of enemas: abdominal pain, painful defecation, nausea, vomiting, flatulency. |
Overall study start date | 01/03/2002 |
Completion date | 01/03/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 8 Years |
Upper age limit | 17 Years |
Sex | Both |
Target number of participants | 78 |
Total final enrolment | 71 |
Key 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 |
Key exclusion criteria | 1. Gastro-intestinal surgery 2. Anorectal anomaly 3. Mental retardation 4. Constipation |
Date of first enrolment | 01/03/2002 |
Date of final enrolment | 01/03/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Pediatric Department
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Website | http://www.amc.uva.nl/ |
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https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (Netherlands)
No information available
Results and Publications
Intention to publish date | |
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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 |
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.