Benign Neoplasm of True Vocal Cords
Conditions
Keywords
phonomicrosurgery, benign vocal fold lesions, voice rest, vhi-10, CPP
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.
Interventions
BEHAVIORALabsolute voice rest
absolute voice rest is the complete elimination of any vocalization (no sounds, speaking or whispering)
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Voice Handicap Index - 10 | 3 months post op |
Secondary
| 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 |
Countries
United States
Outcome results
None listed