Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis: Analysis of Phonatory and Ventilatory Results
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bilateral Vocal Fold Paralysis
- Sponsor
- University Hospital, Rouen
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Maximal phonation time
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
Selective laryngeal bilateral reinnervation as a secondary treatment in patients with bilateral vocal fold paralysis, previously treated by endoscopy, without residual arytenoids ankylosis.
The surgical procedure is : functional reinnervation with the upper root of one phrenic nerve, is used for reinnervation of both cricoarytenoid muscles (laryngeal inspiratory muscles), and simultaneous reinnervation of adductor laryngeal muscles is performed by right and left thyro -hyoid nerves (coming from the hypoglossi) on both sides.
Results are obtained after 6 to 9 months delay. In case of good inspiratory arytenoid abduction, and residual dysphonia, a secondary vocal fold medialization is done by an endoscopic approach 12 months after reinnervation (included in the protocol).
Improvement is expected in voice and breathing, without aspiration.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient with Bilateral vocal fold paralysis in a closure position 6 months to 36 months before.
- •Patient who has been treated by endoscopic treatment without satisfying result (voice or breathing).
- •Patient with passive mobile arytenoid at least on one side
- •Tracheostomized or not
- •Age \> 18 years old
- •Good general situation
Exclusion Criteria
- •Long term vocal fold paralysis (more than 3 years with strong denervation)
- •Ary-cricoid ankylosis or synechiae
- •Age \>75 years
- •Anaesthesiologist contra indication
- •Strong respiratory disease history
- •Severe coagulation troubles
- •Ongoing neoplasia disease
- •Cardiac pace maker
- •Pregnant woman or without contraception
- •Impairment of the freedom
Outcomes
Primary Outcomes
Maximal phonation time
Time Frame: 18 Months
Maximal phonation time will be assessed at 18 Months
Secondary Outcomes
- Voice quality assessed using quality of life questionnaire(18 Months)
- Voice quality assessed using computerized analysis(18 Months)
- Voice quality assessed using swallowing scores(18 Months)