Ethanol submandibular duct ligation for drooling in children with neurodisabilities

• Conditions: 10083624; Speekseklieren; Drooling; 10010335

• Registration Number: NL-OMON50942
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

1. Moderate to severe drooling indicated by Drooling Frequency Score >= 3 or
Drooling 370 Severity Score >= 2. 371
2. Aged 10 years and older. 372
3. Cerebral palsy or any other non-progressive neurodevelopmental disability.
373
4. Contra-indications for a SMDR, or rejection towards a SMDR by patient or
caregivers* 374
5. Ability and willingness to follow the study protocol and attend the 8 and
32-weeks vis-375 its. 376
6. Written and informed consent from caregivers, and when appropriate, oral
consent 377 from the child.

Exclusion Criteria

1. Medical history of salivary gland abnormalities like ductal stenosis,
strictures
2. Previous submandibular salivary gland surgery, or other contraindications
for surgery 385 or general anesthesia. 386
3. Recent (<6 months) glandular Botulinum Neurotoxin A (BoNT-A) injection 387
4. Simultaneous alternative treatment for drooling.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary aim of this study is to evaluate the safety (adverse events and<br /><br>complaints) of the procedure which is defined by adverse events and<br /><br>post-operative complaints (i.e. safety), and surgical time. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include the suitability for an out-patient procedure. </p><br>