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

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ClinicalTrials.gov Identifier: NCT03046706
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

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.

Condition or disease Intervention/treatment Phase
Vocal Fold Polyp Vocal Cord Dysfunction Behavioral: post operative voice rest Behavioral: No voice rest Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Is Voice Rest Contributes to the Quality of Voice After Surgery to Remove Benign Vocal Cord Lesion?
Actual Study Start Date : June 20, 2017
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : March 1, 2019

Arm Intervention/treatment
Active Comparator: standard voice rest
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
After surgery, a week of total silence. In the second week after surgery talking is allowed for 20 minutes a day.

Experimental: no 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
No limitations regarding post operative speech. Members can talk indefinitely after surgery with no special restrictions




Primary Outcome Measures :
  1. Patient's evaluation of his own voice [ Time Frame: 1 month post operative ]
    VHI questionnaire score

  2. Patient's evaluation of his own voice [ Time Frame: 3 months post operative ]
    VHI questionnaire score

  3. Patient's evaluation of his own voice [ Time Frame: 6 months post operative ]
    VHI questionnaire score

  4. doctors evaluation of the patient's voice [ Time Frame: 1 month post operative ]
    GRABS scale score

  5. doctors evaluation of the patient's voice [ Time Frame: 3 month post operative ]
    GRABS scale score

  6. doctors evaluation of the patient's voice [ Time Frame: 6 month post operative ]
    GRABS scale score

  7. voice analysis by a software [ Time Frame: 1 month post operative ]
    jitter score, shrimmer score, harmonic to noise ration

  8. voice analysis by a software [ Time Frame: 3 month ost operative ]
    jitter score, shrimmer score, harmonic to noise ration

  9. voice analysis by a software [ Time Frame: 6 month post operative ]
    jitter score, shrimmer score, harmonic to noise ration


Secondary Outcome Measures :
  1. 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) [ Time Frame: 3 days post operative ]

    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. 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) [ Time Frame: 2 weeks post operative ]

    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. 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) [ Time Frame: 1 month post operative ]

    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.


  4. 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) [ Time Frame: 3 month post operative ]

    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.


  5. 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) [ Time Frame: 6 month post operative ]

    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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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046706


Contacts
Contact: Miki Paker, MD 972-52-6596552 chiefmiki2014@gmail.com
Contact: Jacob Cohen, MD 054-7684433 Jacob_co@hotmail.com

Locations
Israel
Rambam medical center Recruiting
Haifa, Israel, 43654
Contact: jacob cohen, M.D    054223655y    jacob_cohen@hotmail.com   
Contact: miki paker, M.D    0526596552    chiefmiki2014@gmail.com   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Study Director: ziv gil, MD Head of ear nose throat department Rambam medical center Israel

Publications:
Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03046706     History of Changes
Other Study ID Numbers: M.P
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rambam Health Care Campus:
voice rest
laryngeal surgery
glottic polyp
glottic cyst

Additional relevant MeSH terms:
Vocal Cord Dysfunction
Laryngeal Diseases
Respiratory Tract Diseases
Respiration Disorders
Otorhinolaryngologic Diseases