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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 for the conventional post operative voice rest, namely absolute voice rest for a week and another week of relative voice rest (speaking is allowed for 20 minutes a day).
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
Third visit- 14 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard voice rest | Active Comparator | 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 |
|
| no voice rest | Experimental | This group has no limitations regarding post operative speech. Members can talk indefinitely after surgery with no special restrictions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| post operative voice rest | Behavioral | After surgery, a week of total silence. In the second week after surgery talking is allowed for 20 minutes a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient's evaluation of his own voice | VHI questionnaire score | 1 month post operative |
| Patient's evaluation of his own voice | VHI questionnaire score | 3 months post operative |
| Patient's evaluation of his own voice | VHI questionnaire score | 6 months post operative |
| doctors evaluation of the patient's voice | GRABS scale score | 1 month post operative |
| doctors evaluation of the patient's voice | GRABS scale score | 3 month post operative |
| doctors evaluation of the patient's voice | GRABS scale score | 6 month post operative |
| voice analysis by a software | jitter score, shrimmer score, harmonic to noise ration | 1 month post operative |
| voice analysis by a software | jitter score, shrimmer score, harmonic to noise ration | 3 month ost operative |
| voice analysis by a software |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ziv gil, MD | Head of ear nose throat department Rambam medical center Israel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam medical center | Haifa | 43654 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14660924 | Background | Behrman A, Sulica L. Voice rest after microlaryngoscopy: current opinion and practice. Laryngoscope. 2003 Dec;113(12):2182-6. doi: 10.1097/00005537-200312000-00026. | |
| 19660903 | Background | Ishikawa K, Thibeault S. Voice rest versus exercise: a review of the literature. J Voice. 2010 Jul;24(4):379-87. doi: 10.1016/j.jvoice.2008.10.011. Epub 2009 Aug 5. |
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| ID | Term |
|---|---|
| D064706 | Vocal Cord Dysfunction |
| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
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The research group is the group of patients who do not keep voice rest and talk without restrictions or special instructions after surgery.
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| No voice rest | Behavioral | No limitations regarding post operative speech. Members can talk indefinitely after surgery with no special restrictions |
|
jitter score, shrimmer score, harmonic to noise ration |
| 6 month post operative |
| 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. | 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. | 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. | 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. | 6 month post operative |
| 25416241 | Background | Kiagiadaki D, Remacle M, Lawson G, Bachy V, Van der Vorst S. The effect of voice rest on the outcome of phonosurgery for benign laryngeal lesions: preliminary results of a prospective randomized study. Ann Otol Rhinol Laryngol. 2015 May;124(5):407-12. doi: 10.1177/0003489414560583. Epub 2014 Nov 20. |
| 25605690 | Background | Rousseau B, Gutmann ML, Mau T, Francis DO, Johnson JP, Novaleski CK, Vinson KN, Garrett CG. Randomized controlled trial of supplemental augmentative and alternative communication versus voice rest alone after phonomicrosurgery. Otolaryngol Head Neck Surg. 2015 Mar;152(3):494-500. doi: 10.1177/0194599814566601. Epub 2015 Jan 20. |
| 27492336 | Background | Kaneko M, Shiromoto O, Fujiu-Kurachi M, Kishimoto Y, Tateya I, Hirano S. Optimal Duration for Voice Rest After Vocal Fold Surgery: Randomized Controlled Clinical Study. J Voice. 2017 Jan;31(1):97-103. doi: 10.1016/j.jvoice.2016.02.009. Epub 2016 Aug 1. |
| Background | J. A. Koufman, P.D Blalock. Is voice rest never indicated? J. voice Vol 3, No. 1 87-91 |