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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 81
- 试验地点
- 13
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: 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
次要结局
- 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)
- Quality of voice(Baseline, 3 months, 6 months, 9 months and 12 months and at each voice prosthesis replacement)
- Patient quality of voice assessed by the patient's relative(Baseline, at 3 months, 6 months, 9 months and 12 months)
- Time spent out of home(12 months)
- Interruption of oral communication(12 months)
- Frequency of voice prosthesis replacements(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(12 months)
- Quality 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)
- Feeding interruption(12 months)
- Quality of voice assessed by the patient(Baseline, 3 months, 6 months, 9 months and 12 months)
- Annual net financial benefit of developping the use of reinforced prosthesis(5 years)
- 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)
- Trips induced by voice prosthesis replacement(12 months)
- Lifetime of voice prostheses(12 months)
- Complications due to voice prosthesis(12 months)
- Patient's dysphagia due to voice prosthesis replacement(Baseline and at each prosthesis replacement)
- Patient's pain due to voice prosthesis replacement(at each prosthesis replacement, during the 12 months follow-up)