Status:
UNKNOWN
Cost-effectiveness Analysis of Vocal Rehabilitation With Strengthened Tracheoesophageal Voice Implant Prosthesis Versus Standard Voice Prosthesis in Case of Repeated Intra-prosthetic Leakage After Total Laryngectomy
Lead Sponsor:
Nantes University Hospital
Conditions:
Laryngectomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the cost-effectiveness of vocal rehabilitation with reinforced inter-tracheoesophageal voice prosthesis versus standard voice prosthesis in case of repeated i...
Detailed Description
Prosthetic voice rehabilitation is a widespread practice that allows the patient to resume phonation quickly after total laryngectomy/total pharyngolaryngectomy/total circular pharyngolaryngectomy. W...
Eligibility Criteria
Inclusion
- Patient treated surgically by total laryngectomy or total pharyngolaryngectomy or total circular pharyngolaryngectomy and carrying a voice prosthesis for at least 12 months
- Patient carrying a standard voice prosthesis and having undergone 2 successive prosthesis replacements within 3 months of interval and/or requiring at least 4 changes in the last 12 months, for intraprosthetic leakage
- Patients carrying a voice prosthesis, irrespective of the mark/model, of diameters between 16 and 20 French, and of length between 6 and 14 mm.
- Prosthetic replacement available under local or general anaesthesia
- Patient with primary cancer remission status
- Patient agreeing to participate in the study and having given oral, express and informed consent
Exclusion
- Patient with local, regional or metastatic tumor evolution
- Patient who has had a first voice prosthesis for less than 12 months.
- Patient with peri-prosthetic leakage
- Patient presenting a dysfunction of the voice prosthesis not linked to an intra-prosthetic leak
- Patients whose tracheal fistula is no longer opened, or justifying a new tracheoesophageal puncture
- Patients with a voice prosthesis of a diameter strictly greater than 20 French
- Patients with voice prosthesis of strictly less than 6 mm or greater than 14 mm length
- Patient under anti-fungal treatment during the month prior to inclusion
- Adult protected patients
- Inability to complete the questionnaires
- Patients with an estimated life expectancy of less than 1 year
- Patients not affiliated to French National Health care insurance
- Patients under the protection of Justice
- Pregnant woman
Key Trial Info
Start Date :
January 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04100954
Start Date
January 21 2020
End Date
January 31 2024
Last Update
June 6 2023
Active Locations (13)
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1
Chu Bordeaux
Bordeaux, France
2
CHU CAEN
Caen, France
3
Chu Gui de Chauliac
Montpellier, France
4
Chu Nantes
Nantes, France