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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Implementation of a reinforced prosthesis during a medical consultation or under local anesthesia, after removal of the former prosthesis, in case of intraprothetic leakage.
Implementation of a standard prosthesis during a medical consultation or under local anesthesia, after removal of the former prosthesis, in case of intraprothetic leakage.
Chu Bordeaux
Bordeaux, France
CHU CAEN
Caen, France
Chu Gui de Chauliac
Montpellier, France
Chu Nantes
Nantes, France
Chu Nimes
Nîmes, France
Clcc Institut Curie
Paris, France
Hopital Bichat
Paris, France
Hopital Tenon
Paris, France
Chru de Poitiers
Poitiers, France
Chru Pontchaillou
Rennes, France
...and 3 more locations
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
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
Time frame: 12 months
Incremental cost-utility ratio, based on a societal perspective, comparing the use of a reinforced voice prosthesis to the use of a standard one
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 Measure
Time frame: 12 months
Quality of life using Euroqol-5 Dimensions (EQ-5D) questionnaire
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.
Time frame: Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement
Quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
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.
Time frame: Baseline, at 3 months, 6 months, 9 months and 12 months
Quality of life using the Head and Neck Quality of Life Questionnaire (QLQ - H&N 35)
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
Time frame: Baseline, 3 months, 6 months, 9 months and 12 months
Quality of voice
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
Time frame: Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement
Quality of voice assessed by the patient
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
Time frame: Baseline, 3 months, 6 months, 9 months and 12 months
Patient quality of voice assessed by the patient's relative
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 frame: Baseline, at 3 months, 6 months, 9 months and 12 months
Trips induced by voice prosthesis replacement
Number of trips made by the patient for his prosthesis replacement, declared by the patient
Time frame: 12 months
Time spent out of home
Time spent by the patient out of home induced by voice prosthesis leaks, declared by the patient
Time frame: 12 months
Feeding interruption
Number of days or hours during which the patient could not eat due to voice prosthesis leak, declared by the patient
Time frame: 12 months
Interruption of oral communication
Number of days or hours during which the patient could not speak due to voice prosthesis leak, declared by the patient
Time frame: 12 months
Frequency of voice prosthesis replacements
Number of voice prosthesis replacements
Time frame: 12 months
Lifetime of voice prostheses
Date of voice prosthesis replacement
Time frame: 12 months
Complications due to voice prosthesis
Number and type of complications due to voice prosthesis
Time frame: 12 months
Patient's pain due to voice prosthesis replacement
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
Time frame: at each prosthesis replacement, during the 12 months follow-up
Patient's dysphagia due to voice 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.
Time frame: Baseline and at each prosthesis replacement
Annual net financial benefit of developping the use of reinforced prosthesis
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).
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.