Vocal Fold PolypVRNCT04319432
Optimal Duration of Voice Rest After Surgery for Benign Vocal Lesions
A study testing Voice rest in people with Vocal Fold Polyp and Vocal Cord Cyst, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Vocal Fold Polyp, Vocal Cord Cyst, Vocal Nodules in Adults
- What is being tested?
- Voice rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Oct 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients who undergo phonosurgery for benign vocal fold lesions.
- Adults (18-90years).
- Patients who can provide and give informed consent.
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
TASMC
Tel Aviv
YAEL OESTRAICHER, MD, 0526212179, DKYO@netvision.net
About this study
Official title: Optimal Duration of Voice Rest Voice Following Phonosurgery for Benign Vocal Lesions: Prospective Randomized Study.
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.
Read the 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).
- Conditions
- Vocal Fold Polyp, Vocal Cord Cyst, Vocal Nodules in Adults
- Being tested
- Voice rest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice restBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 3 days voice rest | Experimental | Not described Receives: Behavioral: Voice rest |
| 7 days voice rest | Experimental | Not described Receives: Behavioral: Voice rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
better voice quality by GRABS scale
GRABS scale- Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS) each ranked from 0 to 3
Measured: 6 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start12 Oct 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Fold PolypStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yael Oestreicher kedem, MD, Principal investigator, TASMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319432
- Sponsor's protocol ID
- TASMC20YOK037218CTIL
- Acronym
- VR
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Duration of Voice Rest Voice Following Phonosurgery for Benign Vocal Lesions: Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT04319432
- Acronym / sponsor ID
- VR / TASMC20YOK037218CTIL
- Conditions
- Vocal Fold Polyp, Vocal Cord Cyst, Vocal Nodules in Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 3 days voice rest | Experimental | Behavioral: Voice rest |
| 7 days voice rest | Experimental | Behavioral: Voice rest |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Patients who undergo phonosurgery for benign vocal fold lesions.
Key exclusion criteria (4 listed)
- • Patients without a complete medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice restThe 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. | Behavioural | 3 days voice rest, 7 days voice rest |
Primary outcome
better voice quality by GRABS scale
Time frame: 6 months post op
GRABS scale- Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS) each ranked from 0 to 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yael Oestreicher kedem, MD principal investigator
TASMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice rest in people with Vocal Fold Polyp and Vocal Cord Cyst, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yael Oestreicher Kedem, MD (0526212179, DKYO@netvision.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
better voice quality by GRABS scale (time frame: 6 months post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.