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

University of Pittsburgh

Status: Terminated

Conditions: Benign Neoplasm of True Vocal Cords

Treatments: Behavioral: absolute voice rest

Study type: Interventional

Funder types: Other

Identifiers

NCT02634957

PRO15120009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 2 patient groups

3 day absolute voice rest

Experimental group

Description:

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

Treatment:

Behavioral: absolute voice rest

7 day absolute voice rest

Experimental group

Description:

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

Treatment:

Behavioral: absolute voice rest