Research with human participants

Overview of medical research in the Netherlands

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

No registrations found.

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Ethical review
Positive opinion
Status
Recruiting
Health condition type
-
Study type
Interventional

ID

NL-OMON22435

Source

Nationaal Trial Register

Brief title

Botulin-Clip Trial

Health condition

cerebral palsy, drooling, sialorrhea, duct ligation, botulinum toxin

Sponsors and support

Primary sponsor :
Radboud University Medical Centre, Nijmegen
Source(s) of monetary or material Support :
Adriaan Kinderfonds
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.

Public
Universitair Medisch Centrum St Radboud<br>
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
Scientific
Universitair Medisch Centrum St Radboud<br>
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

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Single blinded (masking used)
Control :
Active

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
55
Type :
Anticipated

Positive opinion
Date :
Application type :
First submission

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.

Summary results

N/A