Quality of Life and Voice Perception in Patients Laryngoctomized Phonatory Wearers

Quality of Life Clinical Trial

Official title:

Quality of Life and Voice Perception in Patients Laryngoctomized Phonatory Wearers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086119
• Other study ID #: RS1497/21
• Status: Recruiting
• Start date: May 4, 2021
• Est. completion date: May 4, 2024

Study information

• Verified date: June 2023
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: May 4, 2024
• Est. primary completion date: October 15, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laryngeal Neoplasms
• Larynx Cancer
• Quality of Life

Intervention

Diagnostic Test:
• to assess the voice perception of the patient undergoing phonatory prosthesis placement surgery by evaluating the optimal score (>30) in terms of VHI.
Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome

Sponsors (3)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute	Azienda Policlinico Umberto I, San Giovanni Addolorata Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the patient's quality of life and voice perception underwent surgery for the placement of a voice prosthesis	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-ß) equal to 80% and an a 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)	Enlistment period: 2 years Total duration of the study: 36 months