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NCT Number: NCT01824849

Total Versus Partial Arytenoidectomy in Bilateral Vocal Fold Paralysis

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.

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Key information

Conditions

Airway Obstruction Cranial Nerve Diseases Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Paralysis Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Vagus Nerve Diseases Vocal Cord Paralysis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Hospital

Ankara, 06100, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bilateral vocal fold paralysis

Exclusion criteria

  • Previously operated patients

Treatment and study plan

Total arytenoidectomy

Procedure

Endoscopic total arytenoidectomy was performed on patients with bilateral vocal fold paralysis

Partial arytenoidectomy

Procedure

Endoscopic partial arytenoidectomy was performed on patients with bilateral vocal fold paralysis

Primary outcomes

  1. Decannulation

    Time frame: From the day of operation until 52 weeks after arytenoidectomy

    Preoperative examinations were repeated 1 year after surgery.

Secondary outcomes

  1. Duration of operation

    Time frame: At the day of operation

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

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. Speech intensity

    Time frame: 52 weeks after arytenoidectomy

    Speech intensity is measured in decibels.

  7. 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).

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 5, 2013
Registry last updated
Apr 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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