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

Vocal Fold Polyp Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

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

• NCT number: NCT04319432
• Study type: Interventional
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Yael Oestreicher Kedem, MD
• Phone: 0526212179
• Email: DKYO@netvision.net
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2018
• Completion date: December 31, 2022