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Optimal Duration of Voice Rest After Surgery for Benign Vocal Lesions

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StatusRecruiting
Sponsors
Tel-Aviv Sourasky Medical Center

Keywords

Abstract

Aim of Study:
To determine the optimal duration of voice rest following phonosurgery for patients who undergo phonosurgery due to benign vocal cord lesions IE: vocal fold nodules, cysts, polyps, granulomas, leukoplakia, and subepithelial edema.

Description

Optimal Duration of Voice Rest Voice Following Phonosurgery for benign vocal lesions: Prospective Randomized Study

Background:

Phonosurgery is performed in order to improve voice quality in patients with various vocal fold pathologies including nodules, cysts, polyps, granulomas, leukoplakia, and subepithelial edema. It is customary to order the patients voice rest following vocal fold surgery, however, according to the current literature, it is not well known how long patients should remain in voice rest following phonosurgery (regardless of the type of benign lesion) in order to achieve the best voice quality results. In the literature, there is one preliminary study that shows that when voice quality was assessed at 15 days post-surgery, patients with voice rest of 10 days had better voice outcomes compared to patients with 5 days voice rest(1). A contradicting study, that measured voice outcomes in patients at 1, 3, and 6 months post-operatively, shows that a short voice rest of 3 days lead to better voice results compared to a 7 days voice rest(2).

The aim of our study is to determine the optimal duration (3 versus 7 days) of voice rest following phonosurgery for patients who undergo phonosurgery due to benign vocal cord lesions in order to achieve better voice quality post-operatively. In this study, patients will be randomly assigned into one of 2 different groups of voice rest durations: either 3 or 7 days following surgery. Patients will undergo pre and post (at 1, 3 and 6 months) operative voice testing. Voice quality testing will include: perceptual voice analysis using the GRABS (grade, roughness, asthenia, breathiness, and strain) scale, Voice Handicap Index-10 (VHI) questionnaire, measurement of maximum phonation time (MPT), and computerized voice analysis including voice intensity, fundamental frequency (F0), jitter, shimmer, and dysphonia severity index (DSI).

Dates

Last Verified: 02/29/2020
First Submitted: 03/18/2020
Estimated Enrollment Submitted: 03/22/2020
First Posted: 03/23/2020
Last Update Submitted: 03/22/2020
Last Update Posted: 03/23/2020
Actual Study Start Date: 10/11/2018
Estimated Primary Completion Date: 12/30/2022
Estimated Study Completion Date: 12/30/2022

Condition or disease

Vocal Fold Polyp
Vocal Cord Cyst
Vocal Nodules in Adults

Intervention/treatment

Behavioral: Voice rest

Phase

-

Arm Groups

ArmIntervention/treatment
Experimental: 3 days voice rest
Experimental: 7 days voice rest

Eligibility Criteria

Ages Eligible for Study 18 Years To 18 Years
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Criteria

Inclusion Criteria:

- • Patients who undergo phonosurgery for benign vocal fold lesions.

- Adults (18-90years).

- Patients who can provide and give informed consent.

Exclusion Criteria:

- • Patients without a complete medical record

- Patients who are unable or unwilling to give informed consent

- Patients younger than 18 years of age or older then 90 years

- Patients who are pregnant

Outcome

Primary Outcome Measures

1. better voice quality by GRABS scale [6 months post op]

GRABS scale- Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS) each ranked from 0 to 3

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