Cost-effectiveness Analysis of Vocal Rehabilitation With Strengthened Tracheoesophageal Voice Imp… (NCT04100954) | Clinical Trial Compass
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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
France81 participantsStarted 2020-01-21
Plain-language 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 intra-prosthetic leakage in total laryngectomy patients.
This is a one year medico-economic study involving patients carrying a standard voice prosthesis implant 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.
Eligible subjects will be randomized in 2 groups: reinforced prosthesis with silver coating and double valve (Dual Valve) or standard prosthesis (single unreinforced valve), of the same model as the prosthesis previously implanted in the patient.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incremental Cost-Effectiveness Ratio (cost per avoided prosthesis change), based on a societal perspective, comparing the use of a reinforced voice prosthesis to the use of a standard prosthesis