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2-duct ligation versus botulinum toxin injections for severe drooling in children with cerebral palsy.


- candidate number13158
- NTR NumberNTR3537
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jul-2012
- Secondary IDs2011-022/NL26144.091.11 CMO Regio Arnhem-Nijmegen
- Public Title2-duct ligation versus botulinum toxin injections for severe drooling in children with cerebral palsy.
- Scientific Title2-duct ligation versus botulinum toxin injections for severe drooling in children with cerebral palsy.
- ACRONYMBotulin-Clip Trial
- hypothesisTo objectivy the relative effectiveness of 2-duct ligation versus botulinum toxin in children with cerebral palsy who suffer from excessive drooling despite maximum conservative treatment.
- Healt Condition(s) or Problem(s) studiedCerebral palsy, Botulinum toxin, Duct ligation, Drooling
- Inclusion criteria1. Age > 6 years;
2. Cerebral palsy or other non-progressive neurological disorder;
3. Severe drooling (TDS > 3);
4. Maximal conservative treatment not enough effect;
5. Informed consent;
6. Motivated for follow-up.
- Exclusion criteria1. Former surgery or anatomical variation which makes the procedure impossible;
2. Treatment for drooling at same time;
3. Use of Benzodiazepines.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2012
- planned closingdate1-apr-2016
- Target number of participants55
- InterventionsRandomization of patients between botulin toxin injections and 2-ductligation of the submandibular glands.
- Primary outcome1. Drooling quotient;
2. VAS pain score.
- Secondary outcome1. Impact on life;
2. Complications;
3. Duration of surgery.
- TimepointsAt 1, 8 and 32 weeks patients will be seen in the outpatient clinic.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Saskia Kok
- CONTACT for SCIENTIFIC QUERIESDrs. Saskia Kok
- Sponsor/Initiator Radboud University Nijmegen Medical Centre
- Funding
(Source(s) of Monetary or Material Support)
Johanna Kinderfonds, Phelps Stichting, Adriaan Kinderfonds
- PublicationsN/A
- Brief summaryTo objectivy the relative effectiveness of 2-duct ligation versus botulinum toxin in children with cerebral palsy who suffer from excessive drooling despite maximum conservative treatment.
- Main changes (audit trail)
- RECORD23-jul-2012 - 11-aug-2012


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