NCT01824849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

1.7 years

First QC Date

March 28, 2013

Last Update Submit

April 4, 2013

Conditions

Airway ObstructionVocal Cord Paralysis

Keywords

Vocal cordsVocal cord paralysisArytenoid cartilage

Outcome Measures

Primary Outcomes (1)

  • Decannulation

    Preoperative examinations were repeated 1 year after surgery.

    From the day of operation until 52 weeks after arytenoidectomy

Secondary Outcomes (1)

  • Duration of operation

    At the day of operation

Other Outcomes (7)

  • Voice Handicap Index

    From the day of operation until 52 weeks after arytenoidectomy

  • Acoustic analysis

    From the day operation until 52 weeks after arytenoidectomy

  • Aerodynamic analysis

    From the day of operation until 52 weeks after arytenoidectomy

  • +4 more other outcomes

Study Arms (2)

Total arytenoidectomy

EXPERIMENTAL

Endoscopic total arytenoidectomy was performed on patients.

Procedure: Total arytenoidectomy

Partial arytenoidectomy

EXPERIMENTAL

Endoscopic partial arytenoidectomy was performed on patients.

Procedure: Partial arytenoidectomy

Interventions

Total arytenoidectomyPROCEDURE

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

Total arytenoidectomy
Partial arytenoidectomyPROCEDURE

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

Partial arytenoidectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral vocal fold paralysis

You may not qualify if:

  • Previously operated patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (13)

  • 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.

    PMID: 22865083BACKGROUND

  • 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.

    PMID: 16623972BACKGROUND

  • 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.

    PMID: 13459231BACKGROUND

  • 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.

    PMID: 18418622BACKGROUND

  • 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.

    PMID: 7346673BACKGROUND

  • 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.

    PMID: 8638894BACKGROUND

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

    PMID: 10754363BACKGROUND

  • 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.

    PMID: 15757190BACKGROUND

  • 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.

    PMID: 8427504BACKGROUND

  • 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.

    PMID: 16425557BACKGROUND

  • 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.

    PMID: 21986801BACKGROUND

  • 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.

    PMID: 10580234BACKGROUND

  • 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.

    PMID: 23868428DERIVED

MeSH Terms

Conditions

Airway ObstructionVocal Cord Paralysis

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesLaryngeal DiseasesOtorhinolaryngologic DiseasesVagus Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Taner Yilmaz, MD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 5, 2013

Study Start

January 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

TU(1)