Total Versus Partial Arytenoidectomy in Bilateral Vocal Fold Paralysis

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT01824849
Collaborator
(none)
20
1
2
20
1

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Total arytenoidectomy
  • Procedure: Partial arytenoidectomy
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Decannulation [From the day of operation until 52 weeks after arytenoidectomy]

    Preoperative examinations were repeated 1 year after surgery.

Secondary Outcome Measures

  1. Duration of operation [At the day of operation]

    The duration of operation was measured in minutes at the day of operation.

Other Outcome Measures

  1. Voice Handicap Index [From the day of operation until 52 weeks after arytenoidectomy]

    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.

  2. Acoustic analysis [From the day operation until 52 weeks after arytenoidectomy]

    Fundamental frequency (Hertz), absolute jitter (microseconds), shimmer percent (%), noise to harmonic ratio will be measured as physical measures of voice.

  3. Aerodynamic analysis [From the day of operation until 52 weeks after arytenoidectomy]

    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.

  4. Postoperative breathing ability [52 weeks after arytenoidectomy]

    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).

  5. Subjective comparison of pre- and postoperative voice by a phoniatrician [From the day of operation until 52 weeks after arytenoidectomy]

    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).

  6. Speech intensity [52 weeks after arytenoidectomy]

    Speech intensity is measured in decibels.

  7. Functional outcome swallowing scale [52 weeks after arytenoidectomy]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Bilateral vocal fold paralysis
Exclusion Criteria:
  • Previously operated patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Hospital Ankara Turkey 06100

Sponsors and Collaborators

  • Hacettepe University

Investigators

  • Principal Investigator: Taner Yilmaz, MD, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Taner Yilmaz, Prof. Dr., Hacettepe University
ClinicalTrials.gov Identifier:
NCT01824849
Other Study ID Numbers:
  • HUmedTY1
First Posted:
Apr 5, 2013
Last Update Posted:
Apr 5, 2013
Last Verified:
Apr 1, 2013
Keywords provided by Taner Yilmaz, Prof. Dr., Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2013