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Total Versus Partial Arytenoidectomy in Bilateral Vocal Fold Paralysis

Primary Purpose

Airway Obstruction, Vocal Cord Paralysis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Total arytenoidectomy
Partial arytenoidectomy
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Airway Obstruction focused on measuring Vocal cords, Vocal cord paralysis, Arytenoid cartilage

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Bilateral vocal fold paralysis

Exclusion Criteria:

  • Previously operated patients

Sites / Locations

  • Hacettepe University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Total arytenoidectomy

Partial arytenoidectomy

Arm Description

Endoscopic total arytenoidectomy was performed on patients.

Endoscopic partial arytenoidectomy was performed on patients.

Outcomes

Primary Outcome Measures

Decannulation
Preoperative examinations were repeated 1 year after surgery.

Secondary Outcome Measures

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

Full Information

First Posted
March 28, 2013
Last Updated
April 4, 2013
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT01824849
Brief Title
Total Versus Partial Arytenoidectomy in Bilateral Vocal Fold Paralysis
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 Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
Design: Prospective, randomized, double-blind, case-control Setting: Tertiary, referral, university Patients: Twenty patients with BVFP Intervention: Endoscopic total and partial arytenoidectomy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction, Vocal Cord Paralysis
Keywords
Vocal cords, Vocal cord paralysis, Arytenoid cartilage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total arytenoidectomy
Arm Type
Experimental
Arm Description
Endoscopic total arytenoidectomy was performed on patients.
Arm Title
Partial arytenoidectomy
Arm Type
Experimental
Arm Description
Endoscopic partial arytenoidectomy was performed on patients.
Intervention Type
Procedure
Intervention Name(s)
Total arytenoidectomy
Intervention Description
Endoscopic total arytenoidectomy was performed on patients with bilateral vocal fold paralysis
Intervention Type
Procedure
Intervention Name(s)
Partial arytenoidectomy
Intervention Description
Endoscopic partial arytenoidectomy was performed on patients with bilateral vocal fold paralysis
Primary Outcome Measure Information:
Title
Decannulation
Description
Preoperative examinations were repeated 1 year after surgery.
Time Frame
From the day of operation until 52 weeks after arytenoidectomy
Secondary Outcome Measure Information:
Title
Duration of operation
Description
The duration of operation was measured in minutes at the day of operation.
Time Frame
At the day of operation
Other Pre-specified Outcome Measures:
Title
Voice Handicap Index
Description
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.
Time Frame
From the day of operation until 52 weeks after arytenoidectomy
Title
Acoustic analysis
Description
Fundamental frequency (Hertz), absolute jitter (microseconds), shimmer percent (%), noise to harmonic ratio will be measured as physical measures of voice.
Time Frame
From the day operation until 52 weeks after arytenoidectomy
Title
Aerodynamic analysis
Description
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.
Time Frame
From the day of operation until 52 weeks after arytenoidectomy
Title
Postoperative breathing ability
Description
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).
Time Frame
52 weeks after arytenoidectomy
Title
Subjective comparison of pre- and postoperative voice by a phoniatrician
Description
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).
Time Frame
From the day of operation until 52 weeks after arytenoidectomy
Title
Speech intensity
Description
Speech intensity is measured in decibels.
Time Frame
52 weeks after arytenoidectomy
Title
Functional outcome swallowing scale
Description
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).
Time Frame
52 weeks after arytenoidectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bilateral vocal fold paralysis Exclusion Criteria: Previously operated patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taner Yilmaz, MD
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
22865083
Citation
Yilmaz T. Endoscopic total arytenoidectomy for bilateral abductor vocal fold paralysis: a new flap technique and personal experience with 50 cases. Laryngoscope. 2012 Oct;122(10):2219-26. doi: 10.1002/lary.23467. Epub 2012 Aug 2.
Results Reference
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PubMed Identifier
16623972
Citation
Dursun G, Gokcan MK. Aerodynamic, acoustic and functional results of posterior transverse laser cordotomy for bilateral abductor vocal fold paralysis. J Laryngol Otol. 2006 Apr;120(4):282-8. doi: 10.1017/S0022215106000715.
Results Reference
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PubMed Identifier
13459231
Citation
THORNELL WC. Transoral intralaryngeal approach for arytenoidectomy in bilateral vocal cord paralysis with inadequate airway. Ann Otol Rhinol Laryngol. 1957 Jun;66(2):364-8. No abstract available.
Results Reference
background
PubMed Identifier
18418622
Citation
Sapundzhiev N, Lichtenberger G, Eckel HE, Friedrich G, Zenev I, Toohill RJ, Werner JA. Surgery of adult bilateral vocal fold paralysis in adduction: history and trends. Eur Arch Otorhinolaryngol. 2008 Dec;265(12):1501-14. doi: 10.1007/s00405-008-0665-1. Epub 2008 Apr 17.
Results Reference
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PubMed Identifier
7346673
Citation
Kleinsasser O, Nolte E. [Report on the indication, technique and functional results of endolaryngeal arytenoidectomy and submucous partial chordectomy in bilateral paralysis of vocal cord (author's transl)]. Laryngol Rhinol Otol (Stuttg). 1981 Aug;60(8):397-401. German.
Results Reference
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PubMed Identifier
8638894
Citation
Remacle M, Lawson G, Mayne A, Jamart J. Subtotal carbon dioxide laser arytenoidectomy by endoscopic approach for treatment of bilateral cord immobility in adduction. Ann Otol Rhinol Laryngol. 1996 Jun;105(6):438-45. doi: 10.1177/000348949610500604.
Results Reference
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PubMed Identifier
10754363
Citation
Salassa JR. A functional outcome swallowing scale for staging oropharyngeal dysphagia. Dig Dis. 1999;17(4):230-4. doi: 10.1159/000016941.
Results Reference
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PubMed Identifier
15757190
Citation
Plouin-Gaudon I, Lawson G, Jamart J, Remacle M. Subtotal carbon dioxide laser arytenoidectomy for the treatment of bilateral vocal fold immobility: long-term results. Ann Otol Rhinol Laryngol. 2005 Feb;114(2):115-21. doi: 10.1177/000348940511400206.
Results Reference
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PubMed Identifier
8427504
Citation
Crumley RL. Endoscopic laser medial arytenoidectomy for airway management in bilateral laryngeal paralysis. Ann Otol Rhinol Laryngol. 1993 Feb;102(2):81-4. doi: 10.1177/000348949310200201.
Results Reference
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PubMed Identifier
16425557
Citation
Bosley B, Rosen CA, Simpson CB, McMullin BT, Gartner-Schmidt JL. Medial arytenoidectomy versus transverse cordotomy as a treatment for bilateral vocal fold paralysis. Ann Otol Rhinol Laryngol. 2005 Dec;114(12):922-6. doi: 10.1177/000348940511401205.
Results Reference
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PubMed Identifier
21986801
Citation
Young VN, Rosen CA. Arytenoid and posterior vocal fold surgery for bilateral vocal fold immobility. Curr Opin Otolaryngol Head Neck Surg. 2011 Dec;19(6):422-7. doi: 10.1097/MOO.0b013e32834c1f1c.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Yilmaz T, Suslu N, Atay G, Ozer S, Gunaydin RO, Bajin MD. Comparison of voice and swallowing parameters after endoscopic total and partial arytenoidectomy for bilateral abductor vocal fold paralysis: a randomized trial. JAMA Otolaryngol Head Neck Surg. 2013 Jul;139(7):712-8. doi: 10.1001/jamaoto.2013.3395.
Results Reference
derived

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Total Versus Partial Arytenoidectomy in Bilateral Vocal Fold Paralysis

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