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

University Hospital, Rouen

Status: Completed

Conditions: Bilateral Vocal Fold Paralysis

Treatments: Procedure: Surgery for bilateral laryngeal reinnervation

Study type: Interventional

Funder types: Other

Identifiers

NCT02400008

2011/120/HP

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Patient with bilateral vocal fold paralysis

Experimental group

Description:

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).

Treatment:

Procedure: Surgery for bilateral laryngeal reinnervation