Quality of Life and Voice Perception in Patients Laryngoctomized Phonatory Wearers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- evaluate the patient's quality of life and voice perception underwent surgery for the placement of a voice prosthesis
Study Overview
Brief Summary
Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who will undergo laryngeal demolition surgery, total laryngectomy, who agree to phonatory prosthesis placement
- •Patients who have undergone previous total laryngectomy surgery and intend to undergo placement of phonatory prosthesis.
- •Age > 18 years
- •Written informed consent
Exclusion Criteria
- •Patients who have not undergone demolitive surgical treatment by total laryngectomy or who do not accept the placement of phonatory prosthesis.
- •Patients who are unable to complete questionnaires/follow the rehabilitation pathway
Outcomes
Primary Outcomes
evaluate the patient's quality of life and voice perception underwent surgery for the placement of a voice prosthesis
Time Frame: Enlistment period: 2 years Total duration of the study: 36 months
Evaluate the perception of the voice of the patient undergoing surgery of voice prosthesis positioning, evaluating the optimal score (\>30) in terms of VHI. To calculate the sample size we based our estimate on the percentage of patients not undergoing voice prosthesis with a VHI score greater than 30 (Good Score). Such percentage is approximately 35%, a figure reported in the literature. Assuming a difference of 25% in terms of percentage of patients undergoing voice prosthesis who have a VHI score greater than 30 (60%) to ensure a power (1-β) equal to 80% and an α error of 5%, it will be necessary to enlist a total of 31 patients with the required requirements. Descriptive statistics will be calculated for all variables of interest. The associations will come evaluated using Fisher's exact test. Differences between subgroups will be assessed using the Mann-Whitney U test. All statistical analyzes were conducted using SPSS statistical software (version 21.0)
Secondary Outcomes
No secondary outcomes reported