Optimal Duration of Voice Rest After Surgery for Benign Vocal Lesions

Vocal Fold Polyp Clinical Trial

— VR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04319432
• Other study ID #: TASMC20YOK037218CTIL
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2020
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Yael Oestreicher Kedem, MD
• Phone: 0526212179
• Email: DKYO[@]netvision.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Vocal Cord Cyst
• Vocal Fold Polyp
• Vocal Nodules in Adults

Intervention

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.

Locations

Country	Name	City	State
Israel	TASMC	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	better voice quality by GRABS scale	GRABS scale- Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS) each ranked from 0 to 3	6 months post op