Optimal Duration of Voice Rest After Surgery for Benign Vocal Lesions

Not Applicable

• Conditions: Vocal Cord Cyst; Vocal Fold Polyp; Vocal Nodules in Adults
• Interventions: Behavioral: Voice rest

• Registration Number: NCT04319432
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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 Timeline

• Study Start: 2018-10-12
• Status Verified: 2020-03
• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-23
• Last Update Submitted: 2020-03-23
• Study First Posted: 2020-03-24
• Last Update Posted: 2020-03-24
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 days voice rest	Voice rest	-
7 days voice rest	Voice rest	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

TASMC; 🇮🇱 Tel Aviv, Israel