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

June 13, 2017 updated by: University Hospital, Rouen

Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis: Analysis of Phonatory and Ventilatory Results

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with bilateral vocal fold paralysis
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).
Procedure: Surgery for bilateral laryngeal reinnervation
Surgery for bilateral laryngeal reinnervation assessed for patient with bilateral vocal fold paralysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal phonation time
Time Frame: 18 Months
Maximal phonation time will be assessed at 18 Months
18 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voice quality assessed using quality of life questionnaire
Time Frame: 18 Months
Voice quality will be assessed using quality of life questionnaire, computerized analysis, swallowing scores
18 Months
Voice quality assessed using computerized analysis
Time Frame: 18 Months
Voice quality will be assessed using computerized analysis
18 Months
Voice quality assessed using swallowing scores
Time Frame: 18 Months
Voice quality will be assessed using swallowing scores
18 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Jean-Paul MARIE, Pr, ROUEN university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/120/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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