Impact of Duration Of Absolute Voice Rest on Voice Outcome After Phonomicrosurgery

Absolute voice rest is commonly prescribed after vocal fold surgery, also known as phonomicrosurgery, for benign vocal fold lesions. This is thought to decrease scarring of vocal folds, which could result in increasing tissue stiffness and limitations in optimal vocal outcome. Unfortunately there is no standardized protocol as to how long patients should rest their voice after phonomicrosurgery. To date, there are no studies in the literature directly comparing the impact of short-term and long-term voice rest on vocal fold healing and voice outcome after phonomicrosurgery.

Study Overview

• Status: Terminated
• Conditions: Benign Neoplasm of True Vocal Cords
• Intervention / Treatment: Behavioral: absolute voice rest

Detailed Description

The purpose of this study is to determine whether 3 days versus 7 days of absolute voice rest will result in different voice outcomes in patients who have undergone phonomicrosurgery for benign vocal fold lesions.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with benign mid membranous vocal fold lesions such as the following:

   1. Polyps
   2. Cysts
   3. Sub-epithelial fibrous mass
2. Undergoing elective phonomicrosurgery for vocal fold lesions, which involves microflap excision +/- truncation +/- steroid injection into the vocal folds.
3. Age 18 and older

Exclusion Criteria:

Patients with any of the following will be excluded from the study:

1. Reinke's edema
2. Active smokers
3. Ligamentous mid membranous vocal fold lesions
4. RRP (Recurrent Respiratory Papillomatosis)
5. Dysplasia
6. CIS (Carcinoma-in-situ)
7. SCC (squamous cell carcinoma)
8. Extent of surgery exceeds what is mentioned in the inclusion criteria (e.g., CO2 laser, balloon dilatation, vocal fold augmentation in addition to phonomicrosurgery)
9. Previous vocal fold surgery
10. Systemic steroids
11. History of systemic illness that could affect wound healing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 day absolute voice rest; participants would begin initiation of voice/speaking 3 days post phonomicrosurgery for benign vocal fold lesions	Behavioral: absolute voice rest; absolute voice rest is the complete elimination of any vocalization (no sounds, speaking or whispering)
Experimental: 7 day absolute voice rest; participants would begin initiation of voice/speaking 7 days post phonomicrosurgery for benign vocal fold lesions	Behavioral: absolute voice rest; absolute voice rest is the complete elimination of any vocalization (no sounds, speaking or whispering)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Voice Handicap Index - 10	3 months post op
Voice Handicap Index - 10	1 month post op

Secondary Outcome Measures

Outcome Measure	Time Frame
Cepstral Peak Prominence (CPP)	1 month and 3 months post op
Average phonatory airflow in all voiced sentence	1 month and 3 months post op
video stroboscopy findings	1 month and 3 months post op

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Libby Smith, DO, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: December 11, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 18, 2015

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 13, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: voice rest; CPP; phonomicrosurgery; benign vocal fold lesions; vhi-10
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: PRO15120009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: de-identified information with outside collaborators
• IPD Sharing Time Frame: information may be shared during and after collection for the purpose of analysis
• IPD Sharing Access Criteria: if not part of original IRB, sharing will only occur if there is a data use agreement executed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF