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Clinical Trials/NCT02163772
NCT02163772
Completed
Not Applicable

Early Intracordal Hyaluronic Acid Injection During Spontaneous Reinnervation for Unilateral Recurrent Laryngeal Nerve Paralysis

Chang Gung Memorial Hospital1 site in 1 country29 target enrollmentAugust 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Paralysis, Unilateral, Vocal Cord
Sponsor
Chang Gung Memorial Hospital
Enrollment
29
Locations
1
Primary Endpoint
voice outcome
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Backgrounds: Unilateral vocal cord paralysis caused from recurrent laryngeal nerve (RLN) injury is not an unusual disease and may deteriorate patients'voice and swallowing outcomes. Although the long term treatment effect is encouraged, the point when to perform surgical treatment is not conclusive. Previous reports suggested late treatment principle because patients may spontaneous reinnervation to some degree within 4-5 months after injury. The vocal cord position and tone may change during reinnervation. Others delineated laryngeal synkinesis by misdirected reinnervation is common and suggested early temporary injection laryngoplasty. They implied early injection laryngoplasty may improve patients'not only short term voice outcomes but also decrease the incidence of transcervical laryngeal framework surgery as a determined surgery. However, lacking of prospective study and objective data makes the treatment-time policy still controversial. Purposes: 1. To find incidence of spontaneous reinnervation or synkinetic regeneration. 2. To detect the relationship between changing of glottal gap and laryngeal synkinesis. 3. To detect the impaction of early intracordal hyaluronic acid injection on vocal cord position change in patients with laryngeal synkinesis. Study design: Forty patients is planned to be enrolled in the study. Twenty of them will undergo hyaluronate intracordal injection at three-six month from RLN damage. The other 20 patients will follow the watch-and wait policy. Laryngoscope, laryngeal EMG (electromyography), voice analysis and voice outcome survey will be done at 3-6 month and 12-month after RLN injury. At the end of follow up, the glottal gap, voice laboratory data and quality of life will be compared. The outcomes will also be correlated with laryngeal electromyography (LEMG) data and the impact of synkinetic reinnervation.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
July 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients of untreated unilateral vocal cord paralysis with a known cause of RLN injury within 3-6 month will be enrolled

Exclusion Criteria

  • Patients proved to be not suitable for transcutaneous intracordal injection under topical anesthesia. Those who had previous phonosurgery or can't follow the observation rule will also be excluded.

Outcomes

Primary Outcomes

voice outcome

Time Frame: before intervention and at 6 month follow-up

VOS score: The VOS originally developed by Gliklich et al. comprises a five-item survey that evaluates the physical and social problems associated with unilateral vocal fold palsy.

Secondary Outcomes

  • laryngeal electromyography(before and 6 months post intervention)
  • videolaryngostroboscopy(before and 6 months post intervention)
  • laboratory voice analysis(before and 6 months post intervention)
  • health related quality of life (SF-36)(before and 6 months post intervention)

Study Sites (1)

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