Total Versus Partial Arytenoidectomy in Bilateral Vocal Fold Paralysis

Not Applicable

Completed

• Conditions: Airway Obstruction; Vocal Cord Paralysis
• Interventions: Procedure: Total arytenoidectomy; Procedure: Partial arytenoidectomy

• Registration Number: NCT01824849
• Lead Sponsor: Hacettepe University

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

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2013-03-28
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-04
• Last Update Submitted: 2013-04-04
• Study First Posted: 2013-04-05
• Last Update Posted: 2013-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Bilateral vocal fold paralysis

Exclusion Criteria

• Previously operated patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total arytenoidectomy	Total arytenoidectomy	Endoscopic total arytenoidectomy was performed on patients.
Partial arytenoidectomy	Partial arytenoidectomy	Endoscopic partial arytenoidectomy was performed on patients.

Primary Outcome Measures

Name	Time	Method
Decannulation	From the day of operation until 52 weeks after arytenoidectomy	Preoperative examinations were repeated 1 year after surgery.

Secondary Outcome Measures

Name	Time	Method
Duration of operation	At the day of operation	The duration of operation was measured in minutes at the day of operation.

Trial Locations

Locations (1)

Hacettepe University Hospital; 🇹🇷 Ankara, Turkey