NCT03046706

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

June 20, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

January 29, 2017

Last Update Submit

March 11, 2020

Conditions

Vocal Fold PolypVocal Cord Dysfunction

Keywords

voice restlaryngeal surgeryglottic polypglottic cyst

Outcome Measures

Primary Outcomes (9)

  • 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

    jitter score, shrimmer score, harmonic to noise ration

    6 month post operative

Secondary Outcomes (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)

    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)

    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)

    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)

    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)

    6 month post operative

Study Arms (2)

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

Behavioral: 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.

Behavioral: No voice rest

Interventions

post operative voice restBEHAVIORAL

After surgery, a week of total silence. In the second week after surgery talking is allowed for 20 minutes a day.

standard voice rest
No voice restBEHAVIORAL

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

no voice rest

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam medical center

Haifa, 43654, Israel

Location

Related Publications (6)

  • 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.

    PMID: 14660924BACKGROUND

  • 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.

    PMID: 19660903BACKGROUND

  • 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.

    PMID: 25416241BACKGROUND

  • 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.

    PMID: 25605690BACKGROUND

  • 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.

    PMID: 27492336BACKGROUND

  • J. A. Koufman, P.D Blalock. Is voice rest never indicated? J. voice Vol 3, No. 1 87-91

    BACKGROUND

MeSH Terms

Conditions

Vocal Cord Dysfunction

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesRespiration DisordersOtorhinolaryngologic Diseases

Study Officials

  • ziv gil, MD

    Head of ear nose throat department Rambam medical center Israel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The research group is the group of patients who do not keep voice rest and talk without restrictions or special instructions after surgery.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2017

First Posted

February 8, 2017

Study Start

June 20, 2017

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

IL(1)