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Clinical Trials/NCT02634957
NCT02634957
Terminated
Not Applicable

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

University of Pittsburgh1 site in 1 country17 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Benign Neoplasm of True Vocal Cords
Sponsor
University of Pittsburgh
Enrollment
17
Locations
1
Primary Endpoint
Voice Handicap Index - 10
Status
Terminated
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
January 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Libby Smith DO

Associate Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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)
  • CIS (Carcinoma-in-situ)
  • SCC (squamous cell carcinoma)
  • Extent of surgery exceeds what is mentioned in the inclusion criteria (e.g., CO2 laser, balloon dilatation, vocal fold augmentation in addition to phonomicrosurgery)
  • Previous vocal fold surgery
  • Systemic steroids

Outcomes

Primary Outcomes

Voice Handicap Index - 10

Time Frame: 1 month post op

Secondary Outcomes

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

Study Sites (1)

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