No registrations found.
ID
Source
Brief title
Health condition
cerebral palsy, drooling, sialorrhea, duct ligation, botulinum toxin
Sponsors and support
Phelps Stichting
Johanna Kinderfonds
Intervention
Outcome measures
Primary outcome
>50% reduction in the DQ or caregivers Visual Analogue Scale
Secondary outcome
1. Impact on life;
2. Complications;
3. Duration of surgery.
Background summary
To 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.
Study objective
To 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.
Study design
At 1, 8 and 32 weeks patients will be seen in the outpatient clinic.
Intervention
Randomization of patients between botulin toxin injections and 2-ductligation of the submandibular glands.
Afdeling Keel- Neus- en Oorheelkunde (377)<br>
Postbus 9101
Saskia Kok
Nijmegen 6500 VC
The Netherlands
+31 (0)24 36 14933
s.kok@kno.umcn.nl
Afdeling Keel- Neus- en Oorheelkunde (377)<br>
Postbus 9101
Saskia Kok
Nijmegen 6500 VC
The Netherlands
+31 (0)24 36 14933
s.kok@kno.umcn.nl
Inclusion criteria
1. 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 criteria
1. Former surgery or anatomical variation which makes the procedure impossible;
2. Treatment for drooling at same time;
3. Use of Benzodiazepines.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3395 |
NTR-old | NTR3537 |
Other | CMO Regio Arnhem-Nijmegen : 2011-022/NL26144.091.11 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |