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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimal Duration of Voice Rest After Surgery for Benign Vocal Lesions

NCT04319432

Vocal Fold Polyp Vocal Cord Cyst Vocal Nodules in Adults

UNKNOWN NA

Non-phonatory Exercises in Patients with Unilateral Vocal Fold Paralysis Post-thyroidectomy

NCT05963165

Unilateral Vocal Cord Paralysis

COMPLETED NA

Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Construction Approaches

NCT00600223

Larynx Cancer

COMPLETED

Stapler Versus Conventional Pharyngeal Repair After Total Larygectomy

NCT06256263

Malignant Tumor of the Larynx

COMPLETED NA

A Personalized Voice Restoration Device for Patients With Laryngectomy

NCT05479643

Dysphonia Aphonia

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Benign Neoplasm of True Vocal Cords

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

3 day absolute voice rest

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

Group Type EXPERIMENTAL

absolute voice rest

Intervention Type BEHAVIORAL

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

7 day absolute voice rest

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

Group Type EXPERIMENTAL

absolute voice rest

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

absolute voice rest

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

9. Previous vocal fold surgery
10. Systemic steroids
11. History of systemic illness that could affect wound healing

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No