Total Versus Partial Arytenoidectomy in Bilateral Vocal Fold Paralysis

NCT ID: NCT01824849

Last Updated: 2013-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-09-30

Brief Summary

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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

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

Conditions

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Airway Obstruction Vocal Cord Paralysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Total arytenoidectomy

Endoscopic total arytenoidectomy was performed on patients.

Group Type EXPERIMENTAL

Total arytenoidectomy

Intervention Type PROCEDURE

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

Partial arytenoidectomy

Endoscopic partial arytenoidectomy was performed on patients.

Group Type EXPERIMENTAL

Partial arytenoidectomy

Intervention Type PROCEDURE

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

Interventions

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Total arytenoidectomy

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

Intervention Type PROCEDURE

Partial arytenoidectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Bilateral vocal fold paralysis

Exclusion Criteria

* Previously operated patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Taner Yilmaz

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Taner Yilmaz, MD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 22865083 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16623972 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 13459231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18418622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7346673 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8638894 (View on PubMed)

Salassa JR. A functional outcome swallowing scale for staging oropharyngeal dysphagia. Dig Dis. 1999;17(4):230-4. doi: 10.1159/000016941.

Reference Type BACKGROUND
PMID: 10754363 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15757190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8427504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16425557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21986801 (View on PubMed)

Hillel AD, Benninger M, Blitzer A, Crumley R, Flint P, Kashima HK, Sanders I, Schaefer S. Evaluation and management of bilateral vocal cord immobility. Otolaryngol Head Neck Surg. 1999 Dec;121(6):760-5. doi: 10.1053/hn.1999.v121.a98733.

Reference Type BACKGROUND
PMID: 10580234 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23868428 (View on PubMed)

Other Identifiers

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HUmedTY1

Identifier Type: -

Identifier Source: org_study_id

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