Clinical trial NCT04319432: Optimal Duration of Voice Rest After Surgery for Benign Vocal Lesions
Official title: Optimal Duration of Voice Rest Voice Following Phonosurgery for Benign Vocal Lesions: Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vocal Fold Polyp
Vocal Cord Cyst
Vocal Nodules in Adults
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: better voice quality by GRABS scale
timeFrame: 6 months post op
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: TASMC
Study officials:
affiliation: TASMC
name: Yael Oestreicher kedem, MD
role: PRINCIPAL_INVESTIGATOR
References: