Total Versus Partial Arytenoidectomy in Bilateral Vocal Fold Paralysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taner Yilmaz, Hacettepe University
ClinicalTrials.gov Identifier:
NCT01824849
First received: March 28, 2013
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

Total arytenoidectomy is claimed to increase risk of aspiration and cause more voice loss than other operations performed for bilateral vocal fold paralysis (BVFP). However, objective evidence for such conclusion is lacking. There is no study comparing swallowing and voice after total and partial arytenoidectomy.


Condition Intervention
Airway Obstruction
Vocal Cord Paralysis
Procedure: Total arytenoidectomy
Procedure: Partial arytenoidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparison of Voice and Swallowing Parameters After Endoscopic Total and Partial Arytenoidectomy Using Medially Based Mucosal Advancement Flap Technique for Bilateral Abductor Vocal Fold Paralysis: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Hacettepe University:

Primary Outcome Measures:
  • Decannulation [ Time Frame: From the day of operation until 52 weeks after arytenoidectomy ] [ Designated as safety issue: No ]
    Preoperative examinations were repeated 1 year after surgery.


Secondary Outcome Measures:
  • Duration of operation [ Time Frame: At the day of operation ] [ Designated as safety issue: No ]
    The duration of operation was measured in minutes at the day of operation.


Other Outcome Measures:
  • Voice Handicap Index [ Time Frame: From the day of operation until 52 weeks after arytenoidectomy ] [ Designated as safety issue: No ]
    Voice Handicap Index is a 30-item questionnaire. Possible points change between 0 to 120. Zero means normal voice, 120 means the worst voice. Preoperative examinations were repeated 1 year after surgery.

  • Acoustic analysis [ Time Frame: From the day operation until 52 weeks after arytenoidectomy ] [ Designated as safety issue: No ]
    Fundamental frequency (Hertz), absolute jitter (microseconds), shimmer percent (%), noise to harmonic ratio will be measured as physical measures of voice.

  • Aerodynamic analysis [ Time Frame: From the day of operation until 52 weeks after arytenoidectomy ] [ Designated as safety issue: No ]
    Maximum phonation time (seconds), mean flow rate (liters/second), mean resistance (cmH20/liter/second), mean power (Watt), mean efficiency (ppm) and mean pressure (cmH2O)are obtained as physical measures of aerodynamic analysis.

  • Postoperative breathing ability [ Time Frame: 52 weeks after arytenoidectomy ] [ Designated as safety issue: No ]
    Breathing ability was evaluated on a scale of -2 to +2 (-2: significantly worse; -1: somewhat worse; 0: no change; +1: somewhat better; +2: significantly better).

  • Subjective comparison of pre- and postoperative voice by a phoniatrician [ Time Frame: From the day of operation until 52 weeks after arytenoidectomy ] [ Designated as safety issue: No ]
    Subjective comparison of pre- and postoperative voice on a scale of -2 to +2 (-2: significantly worse; -1: somewhat worse; 0: no change; +1: somewhat better; +2: significantly better).

  • Speech intensity [ Time Frame: 52 weeks after arytenoidectomy ] [ Designated as safety issue: No ]
    Speech intensity is measured in decibels.

  • Functional outcome swallowing scale [ Time Frame: 52 weeks after arytenoidectomy ] [ Designated as safety issue: No ]
    Functional Outcome Swallowing Scale: 0-5 (0: Normal function and asymptomatic; 1: Normal function with episodic or daily symptoms of dysphagia; 2: Compensated abnormal function manifested by significant dietary modifications or prolonged mealtime (without weight loss or aspiration); 3: Decompensated abnormal function with weight loss of <10% of body weight over 6 months due to dysphagia; or daily cough, gagging or aspiration during meals; 4: Severely decompensated abnormal function with weight loss of >10% of body weight over 6 months due to dysphagia; or severe aspiration with bronchopulmonary complications. Non oral feeding for most nutrition; 5: Non oral feeding for all nutrition).


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Total arytenoidectomy
Endoscopic total arytenoidectomy was performed on patients.
Procedure: Total arytenoidectomy
Endoscopic total arytenoidectomy was performed on patients with bilateral vocal fold paralysis
Experimental: Partial arytenoidectomy
Endoscopic partial arytenoidectomy was performed on patients.
Procedure: Partial arytenoidectomy
Endoscopic partial arytenoidectomy was performed on patients with bilateral vocal fold paralysis

Detailed Description:

Design: Prospective, randomized, double-blind, case-control Setting: Tertiary, referral, university Patients: Twenty patients with BVFP Intervention: Endoscopic total and partial arytenoidectomy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bilateral vocal fold paralysis

Exclusion Criteria:

  • Previously operated patients
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01824849

Locations
Turkey
Hacettepe University Hospital
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
Principal Investigator: Taner Yilmaz, MD Hacettepe University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Taner Yilmaz, Prof. Dr., Hacettepe University
ClinicalTrials.gov Identifier: NCT01824849     History of Changes
Other Study ID Numbers: HUmedTY1
Study First Received: March 28, 2013
Last Updated: April 4, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Hacettepe University:
Vocal cords
Vocal cord paralysis
Arytenoid cartilage

Additional relevant MeSH terms:
Vocal Cord Paralysis
Paralysis
Airway Obstruction
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Laryngeal Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on October 19, 2014