VR: Optimal Duration of Voice Rest After Surgery for Benign Vocal Lesions

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04319432

Collaborator

(none)

Enrollment

Location

Arms

50.6

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vocal Fold Polyp Vocal Cord Cyst Vocal Nodules in Adults	Behavioral: Voice rest	N/A

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

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective Study. In this study, patients will be placed into one of two different groups of voice rest duration. The voice rest durations will last either 3 or 7 days. Voice recording results of the different groups will be examined and analyzed. At the conclusion of this study, we hope to provide some clarity as to the optimal duration of voice rest following phonosurgery.Prospective Study. In this study, patients will be placed into one of two different groups of voice rest duration. The voice rest durations will last either 3 or 7 days. Voice recording results of the different groups will be examined and analyzed. At the conclusion of this study, we hope to provide some clarity as to the optimal duration of voice rest following phonosurgery.

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 12, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3 days voice rest	Behavioral: Voice rest The first days will take place in hospitalization to assess patient complience to voice rest. Patients will be instructed to continue voice rest at home up to 7 days accourding to group allocation in the study. The confirmation of voice rest will relay on patient report (telephonic approval), after the voice rest period will end.
Experimental: 7 days voice rest	Behavioral: Voice rest The first days will take place in hospitalization to assess patient complience to voice rest. Patients will be instructed to continue voice rest at home up to 7 days accourding to group allocation in the study. The confirmation of voice rest will relay on patient report (telephonic approval), after the voice rest period will end.

Arm

Intervention/Treatment

Experimental: 3 days voice rest

Behavioral: Voice rest

The first days will take place in hospitalization to assess patient complience to voice rest. Patients will be instructed to continue voice rest at home up to 7 days accourding to group allocation in the study. The confirmation of voice rest will relay on patient report (telephonic approval), after the voice rest period will end.

Experimental: 7 days voice rest

Behavioral: Voice rest

Outcome Measures

Primary Outcome Measures

better voice quality by GRABS scale [6 months post op]
GRABS scale- Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS) each ranked from 0 to 3

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TASMC	Tel Aviv		Israel

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator: Yael Oestreicher kedem, MD, TASMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT04319432

Other Study ID Numbers:

TASMC20YOK037218CTIL

First Posted:

Mar 24, 2020

Last Update Posted:

Mar 24, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 24, 2020