An interventional study of post operative voice rest and No voice rest in Vocal Fold Polyp and Vocal Cord Dysfunction, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-03-12.
Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Treatment
The accepted recommendation after removal of vocal cord lesion is voice rest.This recommendation leads to great tension among the patients, loss of working days and need to practice speech therapy.The investigators hypothesize that voice rest after surgery does not affect the quality of the patient's voice. The investigators will divide the patients into 2 groups: the first group will be instructed for a postoperative voice rest and the second group will not. Later the investigators will compare the results and conclude whether voice rest had any significance.
The prevailing view among laryngologists is that voice rest after laryngeal surgery is important to ensure a good recovery of the epithelium and lamina propria layers of the vocal cord. Speaking immediately after surgery leads to the formation of an irregular collagen in large quantities of the vocal cords - namely the creation scar tissue. The scarred vocal cords leads to a decrease in its elasticity, which is reflected in poor speech quality. Although this theory, not many works were published in the literature proving the necessity for voice rest after vocal cord surgery.
Several studies have been recently published which claim that there is no need for vocal rest and stress the importance of a moderate voice effort straight after surgery. This need is based on the idea that early mobilization of tissue after surgery led to the creation of a healthy soft tissue architecture.
The investigators hypothesize that there is no role for vocal rest after surgery to remove benign lesions from the vocal cords.
Patients candidate for laryngeal surgery that include removal of a benign vocal cord lesion will be divided into two groups:
Patients instructed to speak freely without restrictions after the surgery. those are the study phases: * first visit- preoperative visit.
Lastly the patient is randomized (by block randomization) to determine to which group the patient belongs.
Patients belonging to the control group (standard post operative voice rest) receive a form where they annotate every day whether they kept on the instructed sound regime. This log will allow the investigators to track the compliance of the patients belonging to the voice rest group.
Second visit- 3 days post operative
Same examination as the second visit are performed plus:
- The patient voice will be recorded to determine the GRBAS Index by the laryngologist. recording of the patient's voice for an objective voice analysis evaluation using a computer.
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Exclusion Criteria:
This group maintains postoperative voice rest. Namely, absolute voice rest for a week, followed by a week of relative voice rest sound (talking is allowed for 20 minutes a day). post operative voice rest
Behavioral: post operative voice rest
This group has no limitations regarding post operative speech. Members can talk indefinitely after surgery with no special restrictions.
Behavioral: No voice rest
After surgery, a week of total silence. In the second week after surgery talking is allowed for 20 minutes a day.
No limitations regarding post operative speech. Members can talk indefinitely after surgery with no special restrictions
Patient's evaluation of his own voice
VHI questionnaire score
Time frame: 1 month post operative
Patient's evaluation of his own voice
VHI questionnaire score
Time frame: 3 months post operative
Patient's evaluation of his own voice
VHI questionnaire score
Time frame: 6 months post operative
doctors evaluation of the patient's voice
GRABS scale score
Time frame: 1 month post operative
doctors evaluation of the patient's voice
GRABS scale score
Time frame: 3 month post operative
doctors evaluation of the patient's voice
GRABS scale score
Time frame: 6 month post operative
voice analysis by a software
jitter score, shrimmer score, harmonic to noise ration
Time frame: 1 month post operative
voice analysis by a software
jitter score, shrimmer score, harmonic to noise ration
Time frame: 3 month ost operative
voice analysis by a software
jitter score, shrimmer score, harmonic to noise ration
Time frame: 6 month post operative
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
The next parameters will be evaluated in each visit: 1\. edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value.
Time frame: 3 days post operative
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
The next parameters will be evaluated in each visit: 1\. edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value.
Time frame: 2 weeks post operative
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
The next parameters will be evaluated in each visit: 1\. edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value.
Time frame: 1 month post operative
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
The next parameters will be evaluated in each visit: 1\. edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value.
Time frame: 3 month post operative
Testing the effect of various regimens voice rest on the healing process of vocal cords. the parameters the will be tested are : edema, hyperemia, epithelization, other (presence of granuloma/web)
The next parameters will be evaluated in each visit: 1\. edema- scoring the edema severity .score 1= mild edema .score 2= moderate edema score 3= severe edema hyperemia- scoring the hyperemia severity .score 1= mild hyperemia .score 2= moderate hyperemia score 3= severe hyperemia epithelization degree: 1 =up to 20% 2= up to 50% 3= up to 75% 4- complete epithelization other findings: 1= granuloma 2= web. The final score of each visit includes the sum of all scores separately and will be reported as a single value.
Time frame: 6 month post operative
Plan to share: Undecided
Ran from Jun 2017 to primary completion in Feb 2019, 19 months.
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