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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with bilateral vocal fold paralysis | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery for bilateral laryngeal reinnervation | Procedure | Surgery for bilateral laryngeal reinnervation assessed for patient with bilateral vocal fold paralysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal phonation time | Maximal phonation time will be assessed at 18 Months | 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Voice quality assessed using quality of life questionnaire | Voice quality will be assessed using quality of life questionnaire, computerized analysis, swallowing scores | 18 Months |
| Voice quality assessed using computerized analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul MARIE, Pr | University Hospital, Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rouen University Hospital | Rouen | France |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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Voice quality will be assessed using computerized analysis
| 18 Months |
| Voice quality assessed using swallowing scores | Voice quality will be assessed using swallowing scores | 18 Months |