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The Role of Vocal Rest After Removal of Benign Lesions From Vocal Cord

Primary Purpose

Vocal Fold Polyp, Vocal Cord Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
post operative voice rest
No voice rest
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vocal Fold Polyp focused on measuring voice rest, laryngeal surgery, glottic polyp, glottic cyst

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient Over 18 years old suffers a benign vocal cord lesion and candidate for surgical removal . Recruitment will take place in the voice and Swallowing Clinic. Rambam medical center. Israel.

Exclusion Criteria:

  • A patient under 18.
  • Demented patient.
  • Deaf patient.

Sites / Locations

  • Rambam medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard voice rest

no voice rest

Arm Description

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

This group has no limitations regarding post operative speech. Members can talk indefinitely after surgery with no special restrictions.

Outcomes

Primary Outcome Measures

Patient's evaluation of his own voice
VHI questionnaire score
Patient's evaluation of his own voice
VHI questionnaire score
Patient's evaluation of his own voice
VHI questionnaire score
doctors evaluation of the patient's voice
GRABS scale score
doctors evaluation of the patient's voice
GRABS scale score
doctors evaluation of the patient's voice
GRABS scale score
voice analysis by a software
jitter score, shrimmer score, harmonic to noise ration
voice analysis by a software
jitter score, shrimmer score, harmonic to noise ration
voice analysis by a software
jitter score, shrimmer score, harmonic to noise ration

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
January 29, 2017
Last Updated
March 11, 2020
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT03046706
Brief Title
The Role of Vocal Rest After Removal of Benign Lesions From Vocal Cord
Official Title
Is Voice Rest Contributes to the Quality of Voice After Surgery to Remove Benign Vocal Cord Lesion?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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. First the investigators prove by fiber optic examination that the patient suffers from the scourge of benign vocal cord lesion. Then the patient gets an explanation of the study, fill a demographic questionnaire. Next the patient fills the VHI (voice handicap index) questionnaire - a questionnaire which assesses the impact of the patient voice by 3 measures:emotional,functional and psychosocial. The questionnaire contains 30 questions. Any question dotted between 0-4 by the patient so that a higher score means more bad sound. Optical fiber testing is performed. Vocal cords including the lesion are photographed and video files are saved . Stroboscopic test for determining the quality of vibration, movement and closure of the vocal cords.The patient voice is recorded for future determination of the GRBAS (Grade,Roughness, breathiness, asthenia,strain). this index, scored by the laryngologists assesses the patient's voice according to five factors- grade, roughness, breathiness, asthenia,strain. Each parameter dotted between 0-3 so a higher score means more bad sound.The last test is objective. The voice recording will undergo computer analysis which determine the following voice objectives : fundamental frequency, jitter, shimmer, harmonic to noise ratio. 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 Execute an optical fiber examination for description and evaluation of the recovery process of the vocal cord. Vocal cords including the lesion will be photographed and video files are saved. stroboscopic test for future determination of the quality of vibration, movement and closure of the vocal cods. 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. Forth visit- 1 months post operative. Same examinations as the second visit are performed. Fifth visit- 3 months post operative. Same examinations as the second visit are performed plus patient fills VHI questionnaire. Sixth visit- 6 months post operative. Same examinations as the fifth visit are performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Fold Polyp, Vocal Cord Dysfunction
Keywords
voice rest, laryngeal surgery, glottic polyp, glottic cyst

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The research group is the group of patients who do not keep voice rest and talk without restrictions or special instructions after surgery.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard voice rest
Arm Type
Active Comparator
Arm Description
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
Arm Title
no voice rest
Arm Type
Experimental
Arm Description
This group has no limitations regarding post operative speech. Members can talk indefinitely after surgery with no special restrictions.
Intervention Type
Behavioral
Intervention Name(s)
post operative voice rest
Intervention Description
After surgery, a week of total silence. In the second week after surgery talking is allowed for 20 minutes a day.
Intervention Type
Behavioral
Intervention Name(s)
No voice rest
Intervention Description
No limitations regarding post operative speech. Members can talk indefinitely after surgery with no special restrictions
Primary Outcome Measure Information:
Title
Patient's evaluation of his own voice
Description
VHI questionnaire score
Time Frame
1 month post operative
Title
Patient's evaluation of his own voice
Description
VHI questionnaire score
Time Frame
3 months post operative
Title
Patient's evaluation of his own voice
Description
VHI questionnaire score
Time Frame
6 months post operative
Title
doctors evaluation of the patient's voice
Description
GRABS scale score
Time Frame
1 month post operative
Title
doctors evaluation of the patient's voice
Description
GRABS scale score
Time Frame
3 month post operative
Title
doctors evaluation of the patient's voice
Description
GRABS scale score
Time Frame
6 month post operative
Title
voice analysis by a software
Description
jitter score, shrimmer score, harmonic to noise ration
Time Frame
1 month post operative
Title
voice analysis by a software
Description
jitter score, shrimmer score, harmonic to noise ration
Time Frame
3 month ost operative
Title
voice analysis by a software
Description
jitter score, shrimmer score, harmonic to noise ration
Time Frame
6 month post operative
Secondary Outcome Measure Information:
Title
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)
Description
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
Title
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)
Description
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
Title
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)
Description
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
Title
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)
Description
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
Title
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)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient Over 18 years old suffers a benign vocal cord lesion and candidate for surgical removal . Recruitment will take place in the voice and Swallowing Clinic. Rambam medical center. Israel. Exclusion Criteria: A patient under 18. Demented patient. Deaf patient.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ziv gil, MD
Organizational Affiliation
Head of ear nose throat department Rambam medical center Israel
Official's Role
Study Director
Facility Information:
Facility Name
Rambam medical center
City
Haifa
ZIP/Postal Code
43654
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
14660924
Citation
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.
Results Reference
background
PubMed Identifier
19660903
Citation
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.
Results Reference
background
PubMed Identifier
25416241
Citation
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.
Results Reference
background
PubMed Identifier
25605690
Citation
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.
Results Reference
background
PubMed Identifier
27492336
Citation
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.
Results Reference
background
Citation
J. A. Koufman, P.D Blalock. Is voice rest never indicated? J. voice Vol 3, No. 1 87-91
Results Reference
background

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The Role of Vocal Rest After Removal of Benign Lesions From Vocal Cord

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