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Surgery for Vocal Cord Paralysis

NCT ID: NCT00064571

Last Updated: 2006-04-24

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2005-10-31

Brief Summary

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Unilateral vocal fold paralysis (UVFP) is caused by injury to the nerve to the affected vocal fold. The injury to the vocal fold makes the affected person's voice sound "breathy". Voice therapy is usually tried first, and, if unsuccessful, surgical treatment is considered. The standard surgical treatment is called vocal fold medialization and aims to bring the injured cord to the midline. An alternative surgical treatment, vocal fold reinnervation, aims to bring a new nerve supply to the injured vocal fold. The reinnervation operation, which has some potential advantages over the medialization operation also requires several months for final results to be gained. The goal of this multicenter, randomized clinical trial is to see which of the two surgical treatments produces a better outcome.

In order to participate in this study patients with UVFP must meet all entry criteria and must be released from voice therapy by a speech-language pathologist. Information collected for the study (pre-surgery, and at 6 and 12 months after surgery) includes voice recordings, movies made of vocal fold function, airflow and pressure measurements of the voicebox, and an outcomes questionnaire.

Detailed Description

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Unilateral vocal fold paralysis (UVFP) is caused by injury to the recurrent laryngeal nerve. Patients with UVFP may have significant impairment of vocal fold function, including a breathy paralytic dysphonia. There are several available approaches for the treatment of this condition. Vocal fold medialization is currently used by most otolaryngologists and is probably the standard of care for treating UVFP. An alternative approach is laryngeal reinnervation, which has a number of potential advantages over medialization but which requires several months before a final result is achieved. The primary goal of this multicenter, randomized clinical trial is to determine which approach produces a better outcome.

Patients with UVFP meeting all inclusion criteria and released from therapy by a speech-language pathologist will be randomized into either the medialization arm or the reinnervation arm. The data collection protocol consists of voice recordings, aerodynamic measurements, electroglottography, videostroboscopy, and a clinical outcomes questionnaire collected pre-treatment and at 6 and 12 months post-treatment.

Conditions

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Unilateral Vocal Cord Paralysis

Keywords

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unilateral vocal fold paralysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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vocal fold medialization

Intervention Type PROCEDURE

vocal fold reinnervation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of unilateral vocal fold paralysis
* older than 18 years of age
* intact ansa cervicalis and recurrent laryngeal nerves
* life expectancy of greater than 2 years
* onset of the vocal fold paralysis within 2 years of the time of surgery
* no gelfoam injection for at least 4 months prior to initial data collection
* able to give informed consent
* willing and able to return for 6 and 12 month data collection sessions
* able and willing to perform questionnaire (by mail) 18 months after surgery

Exclusion Criteria

* abnormal non-paralyzed fold
* other disorders affecting the larynx (voice box), such as multiple sclerosis, myasthenia gravis, spasmodic dysphonia, or essential voice tremor
* prior surgery to either vocal fold
* previous or planned irradiation of the voicebox
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role lead

Principal Investigators

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Randal C Paniello, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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University of Alabama-Birmingham

Birmingham, Alabama, United States

Site Status

UC-Irvine Medical Center

Irvine, California, United States

Site Status

George Washington University

Washington D.C., District of Columbia, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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U01DC004681

Identifier Type: NIH

Identifier Source: org_study_id

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