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Clinical Trials/NCT04319432
NCT04319432UnknownNot Applicable

Optimal Duration of Voice Rest Voice Following Phonosurgery for Benign Vocal Lesions: Prospective Randomized Study.

Tel-Aviv Sourasky Medical Center1 site in 1 country40 target enrollmentStarted: October 12, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
40
Locations
1
Primary Endpoint
better voice quality by GRABS scale

Study Overview

Brief Summary

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.

Detailed 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

better voice quality by GRABS scale

Time Frame: 6 months post op

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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