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

NCT02634957 | Terminated DMC

• 1 other identifier: PRO15120009
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Neoplasm of True Vocal Cords

Keywords

phonomicrosurgery; benign vocal fold lesions; voice rest; vhi-10; CPP

Outcome Measures

Primary Outcomes (2)

• Voice Handicap Index - 10

  3 months post op

• Voice Handicap Index - 10

  1 month post op

Secondary Outcomes (3)

• 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

Study Arms (2)

3 day absolute voice rest

EXPERIMENTAL

participants would begin initiation of voice/speaking 3 days post phonomicrosurgery for benign vocal fold lesions

Behavioral: absolute voice rest

7 day absolute voice rest

EXPERIMENTAL

participants would begin initiation of voice/speaking 7 days post phonomicrosurgery for benign vocal fold lesions

Behavioral: absolute voice rest

Interventions

absolute voice rest BEHAVIORAL

absolute voice rest is the complete elimination of any vocalization (no sounds, speaking or whispering)

3 day absolute voice rest; 7 day absolute voice rest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with benign mid membranous vocal fold lesions such as the following:
• Polyps
• Cysts
• Sub-epithelial fibrous mass
• Undergoing elective phonomicrosurgery for vocal fold lesions, which involves microflap excision +/- truncation +/- steroid injection into the vocal folds.
• Age 18 and older

You may not qualify if:

• Patients with any of the following will be excluded from the study:
• Reinke's edema
• Active smokers
• Ligamentous mid membranous vocal fold lesions
• RRP (Recurrent Respiratory Papillomatosis)
• Dysplasia
• CIS (Carcinoma-in-situ)
• SCC (squamous cell carcinoma)
• Previous vocal fold surgery
• Systemic steroids
• History of systemic illness that could affect wound healing

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

Study Officials

• Libby Smith, DO

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 18, 2015
• Study Start: January 1, 2016
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: information may be shared during and after collection for the purpose of analysis
• Access Criteria: if not part of original IRB, sharing will only occur if there is a data use agreement executed.

Locations

US (1)