Total Versus Partial Arytenoidectomy in Bilateral Vocal Fold Paralysis

April 4, 2013 updated by: Taner Yilmaz, Hacettepe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

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 Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University Hospital

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:

  • Bilateral vocal fold paralysis

Exclusion Criteria:

  • Previously operated patients

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decannulation
Time Frame: From the day of operation until 52 weeks after arytenoidectomy
Preoperative examinations were repeated 1 year after surgery.
From the day of operation until 52 weeks after arytenoidectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of operation
Time Frame: At the day of operation
The duration of operation was measured in minutes at the day of operation.
At the day of operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voice Handicap Index
Time Frame: 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.
From the day of operation until 52 weeks after arytenoidectomy
Acoustic analysis
Time Frame: 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.
From the day operation until 52 weeks after arytenoidectomy
Aerodynamic analysis
Time Frame: 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.
From the day of operation until 52 weeks after arytenoidectomy
Postoperative breathing ability
Time Frame: 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).
52 weeks after arytenoidectomy
Subjective comparison of pre- and postoperative voice by a phoniatrician
Time Frame: 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).
From the day of operation until 52 weeks after arytenoidectomy
Speech intensity
Time Frame: 52 weeks after arytenoidectomy
Speech intensity is measured in decibels.
52 weeks after arytenoidectomy
Functional outcome swallowing scale
Time Frame: 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).
52 weeks after arytenoidectomy

Collaborators and Investigators

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

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Taner Yilmaz, MD, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Estimate)

April 5, 2013

Last Update Submitted That Met QC Criteria

April 4, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUmedTY1

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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