Optimal Duration of Voice Rest After Surgery for Benign Vocal Lesions
VR
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2018
CompletedFirst Submitted
Initial submission to the registry
March 19, 2020
CompletedFirst Posted
Study publicly available on registry
March 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 24, 2020
March 1, 2020
4.2 years
March 19, 2020
March 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
better voice quality by GRABS scale
GRABS scale- Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS) each ranked from 0 to 3
6 months post op
Study Arms (2)
3 days voice rest
EXPERIMENTAL7 days voice rest
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Patients who undergo phonosurgery for benign vocal fold lesions.
- Adults (18-90years).
- Patients who can provide and give informed consent.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
TASMC
Tel Aviv, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Yael Oestreicher kedem, MD
TASMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2020
First Posted
March 24, 2020
Study Start
October 12, 2018
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
March 24, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share
Anonymization of study patients Patient information (I.e. name, ID number, etc.) will be collected and kept confidential throughout the study so that the patients cannot be re-traced or identified. The information will be gathered by the main investigator kept in an encrypted file with a password required for access on the main researcher's computer. Information will not be sent or distributed outside the hospital to anyone.