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

Not Applicable

Terminated

• Conditions: Benign Neoplasm of True Vocal Cords
• Interventions: Behavioral: absolute voice rest

• Registration Number: NCT02634957
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2015-12-11
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-18
• Study Start: 2016-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-13
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7 day absolute voice rest	absolute voice rest	participants would begin initiation of voice/speaking 7 days post phonomicrosurgery for benign vocal fold lesions
3 day absolute voice rest	absolute voice rest	participants would begin initiation of voice/speaking 3 days post phonomicrosurgery for benign vocal fold lesions

Primary Outcome Measures

Name	Time	Method
Voice Handicap Index - 10	1 month post op

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States