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Trial Title:
Quality of Life and Voice Perception in Patients Laryngoctomized Phonatory Wearers
NCT ID:
NCT06086119
Condition:
Quality of Life
Larynx Cancer
Conditions: Official terms:
Laryngeal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
to assess the voice perception of the patient undergoing phonatory prosthesis placement surgery by evaluating the optimal score (>30) in terms of VHI.
Description:
Prospective, multicenter observational study involving patients who will undergo total
laryngectomy surgery and placement of phonatory prosthesis
Arm group label:
Patients who will be subjected to total laryngectomy and placement of voice prosthesis
Summary:
Prospective, multicenter observational study involving patients who will undergo total
laryngectomy surgery and placement of phonatory prosthesis.
Criteria for eligibility:
Study pop:
Prospective, multicenter observational study involving patients who will undergo total
laryngectomy surgery and placement of phonatory prosthesis.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
"Regina Elena" National Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Raul Pellini, MD
Phone:
ND
Email:
raul.pellini@ifo.it
Start date:
May 4, 2021
Completion date:
May 4, 2024
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Collaborator:
Agency:
San Giovanni Addolorata Hospital
Agency class:
Other
Collaborator:
Agency:
Azienda Policlinico Umberto I
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06086119
