Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis

Not Applicable

• Conditions: Bilateral Vocal Fold Paralysis
• Interventions: Procedure: Surgery for bilateral laryngeal reinnervation

• Registration Number: NCT02400008
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with bilateral vocal fold paralysis	Surgery for bilateral laryngeal reinnervation	Patient with bilateral vocal fold paralysis in a closure position between 6 months to 36 months before et who has been treated by endoscopic treatment without satisfying result (voice or breathing).

Primary Outcome Measures

Name	Time	Method
Maximal phonation time	18 Months	Maximal phonation time will be assessed at 18 Months

Secondary Outcome Measures

Name	Time	Method
Voice quality assessed using quality of life questionnaire	18 Months	Voice quality will be assessed using quality of life questionnaire, computerized analysis, swallowing scores
Voice quality assessed using computerized analysis	18 Months	Voice quality will be assessed using computerized analysis
Voice quality assessed using swallowing scores	18 Months	Voice quality will be assessed using swallowing scores

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France