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
- Conditions
- Laryngectomy
- Interventions
- Device: Standard prosthesisDevice: Reinforced prosthesis
- Registration Number
- NCT04100954
- Lead Sponsor
- Nantes University Hospital
- 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 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.
- 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.
When the longevity of the implant is abnormally short (less than 3 months), the multiplication of changes is likely to increase the risk of overall morbidity related to maintaining the functionality of the voice prosthesis and to alter the patient's quality of life.
Reinforced innovative prostheses, currently not supported by the French Social Security, delay the occurrence of intraprosthetic leakage compared to standard prostheses.
This study assesses the economic efficiency from a societal perspective and a one-year time horizon, from vocal rehabilitation with reinforced inter-tracheoesophageal prosthesis versus standard voice prosthesis in case of intra-tracheal leakage in total laryngectomy patients.
Patients are randomized in 2 arms. Arm A usual care with reinforced prosthesis, or arm B usual care with standard prosthesis. Each patient is followed during 12 months.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 81
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard prosthesis Standard prosthesis Implementation of a standard prosthesis (simple valve, not reinforced), similar to the prosthesis the patient previously had. Reinforced prosthesis Reinforced prosthesis Implementation of a reinforced prosthesis with silver coating and double valve, whatever which type of prosthesis the patient previously had.
- Primary Outcome Measures
Name Time Method 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 12 months Effectiveness will be measured by the mean of number of prosthesis changes in each arm. Costs will be measured by 1) Outpatient resource consumption collected in a declarative patient questionnaire and 2) Hospital care resources using the database of the Medicalised Information System Program of each recruiting site
- Secondary Outcome Measures
Name Time Method Quality of life using the Head and Neck Quality of Life Questionnaire (QLQ - H&N 35) Baseline, 3 months, 6 months, 9 months and 12 months Score of the QLQ - H\&N 35, including 35 questions assessing other aspects of quality of life in patients with head and neck cancer. The total score ranges from 0 to 100
Quality of voice Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement score of the Voice Handicap Index: 10 items assessing the patient's voice, with 5 possible answers per item ranking from "never" to "always". The total score ranges from 0 to 120
Patient quality of voice assessed by the patient's relative Baseline, at 3 months, 6 months, 9 months and 12 months Voice quality assessed by the patient's relative if present at time of prosthesis replacement, with a numeric scale ranging from 0 "worst possible voice" to 10 "best possible voice", before and after each voice prosthesis change
Time spent out of home 12 months Time spent by the patient out of home induced by voice prosthesis leaks, declared by the patient
Interruption of oral communication 12 months Number of days or hours during which the patient could not speak due to voice prosthesis leak, declared by the patient
Frequency of voice prosthesis replacements 12 months Number of voice prosthesis replacements
Incremental cost-utility ratio, based on a societal perspective, comparing the use of a reinforced voice prosthesis to the use of a standard one 12 months Utility will be measured by Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D 5L) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible.
Cost will be measured as described in the Primary Outome MeasureQuality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Baseline, at 3 months, 6 months, 9 months and 12 months Score of the QLQ-C30 questionnaire, including 30 questions assessing some aspects of the quality of life of cancer patients. The total score ranges from 0 to 100.
Feeding interruption 12 months Number of days or hours during which the patient could not eat due to voice prosthesis leak, declared by the patient
Quality of voice assessed by the patient Baseline, 3 months, 6 months, 9 months and 12 months Voice quality assessed by the patient and by a patient's relative with a numeric scale ranging from 0 "worst possible voice" to 10 "best possible voice", before and after each voice prosthesis change
Annual net financial benefit of developping the use of reinforced prosthesis 5 years Net financial benefit of the development of reinforced phonatory implants' compared to standard implants'use for patients treated with thyroid lobectomy and with repeated intraprosthetic dysfunction, through a Budget Impact Analysis (BIA) with a 5-years' time horizon and a National Health Insurance's perspective (NHI).
Methods: Financial consequences for the NHI of several scenarii of development of the reinforced phonatory implants' will be represented in a table, year by year and over 5 years, in terms of cost per scenario and in terms of cost difference between the scenarii (showing savings or additional costs generated by choosing to develop the reinforced phonatory implant).Quality of life using Euroqol-5 Dimensions (EQ-5D) questionnaire Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement Score of EQ-5D 5L. health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible, each answer corresponds to a score ranging from 1 to 5.
Trips induced by voice prosthesis replacement 12 months Number of trips made by the patient for his prosthesis replacement, declared by the patient
Lifetime of voice prostheses 12 months Date of voice prosthesis replacement
Complications due to voice prosthesis 12 months Number and type of complications due to voice prosthesis
Patient's dysphagia due to voice prosthesis replacement Baseline and at each prosthesis replacement Score of the Dysphagia Handicap Index 10 items assessing the patient's dysphagia, with 5 possible answers per item ranking from "never" to "always". Total score ranges from 0 to 120.
Patient's pain due to voice prosthesis replacement at each prosthesis replacement, during the 12 months follow-up Pain due to voice prosthesis replacement assessed by a numeric scale ranging from 0 "no pain" to 10 "worst pain", asked to the patient before and after each voice prosthesis change
Trial Locations
- Locations (13)
Chu Bordeaux
🇫🇷Bordeaux, France
Clcc Institut Curie
🇫🇷Paris, France
CHU CAEN
🇫🇷Caen, France
Chu Gui de Chauliac
🇫🇷Montpellier, France
Chu Nantes
🇫🇷Nantes, France
Hopital Bichat
🇫🇷Paris, France
Chu Nimes
🇫🇷Nîmes, France
Chru de Poitiers
🇫🇷Poitiers, France
Chru Pontchaillou
🇫🇷Rennes, France
Hopital Tenon
🇫🇷Paris, France
Hopital Hautepierre
🇫🇷Strasbourg, France
Institut Universitaire du Cancer de Toulouse-Oncopole
🇫🇷Toulouse, France
Institut de Cancerologie de Lorraine
🇫🇷Vandœuvre-lès-Nancy, France