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

Benign Neoplasm of True Vocal Cords Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02634957
• Other study ID #: PRO15120009
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Neoplasm of True Vocal Cords
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voice Handicap Index - 10		3 months post op
Primary	Voice Handicap Index - 10		1 month post op
Secondary	Cepstral Peak Prominence (CPP)		1 month and 3 months post op
Secondary	Average phonatory airflow in all voiced sentence		1 month and 3 months post op
Secondary	video stroboscopy findings		1 month and 3 months post op