Health Economic Impact of Robot-assisted Bariatric Surgery vs Conventional Laparoscopy: Prospective Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 482
- 试验地点
- 35
- 主要终点
- Incremental cost-effectivEness ratio (ICER)
研究概览
简要总结
CONTEXT :
Obesity is a serious disease which affects 17% of the french population. Bariatric and metabolic surgery has demonstrated its efficiency and remains the treatment of reference. Over 40,000 bariatric procedures are performed per year, mainly by laparoscopy ; the robotic approach, historically developed by Intuitive Surgical increases rapidly and accounts for 18% of the procedures in the public system. Whereas the robotic approach has demonstrated its superiority toward laparoscopy for prostatectomies and rectal resections, it still has to be demonstrated for bariatric surgery ; some studies report a decrease rate of complications for complexe procedures and selected patients but the literature remains variable and the benefit of the robot in relation to its high cost must be confirmed.
OBJECTIVES:
To conduct a health-economic assessment (i.e. cost-effectiveness ratio expressed as the additional cost per quality adjusted life-year gained) of the Da Vinci robot in bariatric surgery at 1 year, from the Health Care system point of view.
METHOD :
Randomized (482 patients), controlled, single-blind, multicenter, superiority trial comparing two approaches for primary or revisional bariatric surgery: a group benefiting from a robotic approach and a reference group benefiting from a laparoscopic approach. Data from the trial will be matched via the social security number to the French National Health Insurance Information System (SNDS database) in order to collect care consumption. The quality of life will be assessed using the EuroQol-5 Dimension (EQ5D-5L) questionnaire.
PERSPECTIVES:
This study will have a direct impact on patients care, professional practices and public health policy either by validating the value of the robot in bariatric surgery or conversely, by promoting the laparoscopic approach.
HYPOTHESIS :
Robot-assisted bariatric surgery is more expensive than conventional laparoscopy, but the additional costs associated with the robot are partly offset by a reduction in post-operative complications at 1 year, which should also help to improve patients' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Single-blind study: patient will not be informed of the approach (laparoscopic or robotic) which will be used for their intervention.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged between 18 and 70 years old,
- •Female or male patients
- •Patient eligible for one of the two situations defined below:
- •Primary bariatric or metabolic surgery, with a BMI corresponding to one of the 3 following situations, in accordance with the french National Authority for Health (HAS) recommendations published in February 2024:
- •40 kg/m² OR
- •35 kg/m² with at least one comorbidity that may improve after surgery (e.g.: high blood pressure, sleep apnea syndrome and other severe respiratory disorders, type 2 diabetes, disabling osteoarticular diseases, steatohepatitis not alcoholic, dyslipidemia, osteoarthritis) OR between 30 and 35 kg/m² with uncontrolled type 2 diabetes
- •Revision surgery for complication and/or side effects of a previous bariatric surgery
- •Patient who has benefited from a pluridisciplinary evaluation (medical, surgical, psychiatric), with a favorable opinion for a bariatric.
- •Patient who agrees to be included in the study and who signs the informed consent form,
排除标准
- •Presence of a severe and evolutive life threatening pathology, unrelated to obesity,
- •Pregnancy or desire to be pregnant during the study,
- •Patient not affiliated to a French or European healthcare insurance,
- •Patient under supervision or guardianship
- •Patient who is unable to give consent,
- •Patient who does not understand French
- •Patient who has already been included in a trial which has a conflict of interests with the present study
研究组 & 干预措施
Conventional laparoscopic surgical strategy
Primary bariatric surgery (According to the recommendations of the High Authority of Health: patient with a BMI ≥40 kg/m2 and/or BMI ≥35 kg/m2 associated with at least one comorbidity and/or BMI between 30 and 35 kg/m2 and suffering from type 2 diabetes) or revision bariatric surgery (for complications or side effects of a previous surgery), using a conventional laparoscopic approach.
干预措施: Impact of Weight on Quality of Life (IWQOL) questionnaire (Other)
Robot-assisted surgical strategy
Primary bariatric surgery (According to the recommendations of the High Authority of Health: patient with a BMI ≥40 kg/m2 and/or BMI ≥35 kg/m2 associated with at least one comorbidity and/or BMI between 30 and 35 kg/m2 and suffering from type 2 diabetes) or revision bariatric surgery (for complications or side effects of a previous surgery), using a robotic approach.
干预措施: Robot-assisted surgical strategy (Procedure)
Robot-assisted surgical strategy
Primary bariatric surgery (According to the recommendations of the High Authority of Health: patient with a BMI ≥40 kg/m2 and/or BMI ≥35 kg/m2 associated with at least one comorbidity and/or BMI between 30 and 35 kg/m2 and suffering from type 2 diabetes) or revision bariatric surgery (for complications or side effects of a previous surgery), using a robotic approach.
干预措施: Visual analog scale (Other)
Robot-assisted surgical strategy
Primary bariatric surgery (According to the recommendations of the High Authority of Health: patient with a BMI ≥40 kg/m2 and/or BMI ≥35 kg/m2 associated with at least one comorbidity and/or BMI between 30 and 35 kg/m2 and suffering from type 2 diabetes) or revision bariatric surgery (for complications or side effects of a previous surgery), using a robotic approach.
干预措施: EQ-5D-5L questionnaire (Other)
Robot-assisted surgical strategy
Primary bariatric surgery (According to the recommendations of the High Authority of Health: patient with a BMI ≥40 kg/m2 and/or BMI ≥35 kg/m2 associated with at least one comorbidity and/or BMI between 30 and 35 kg/m2 and suffering from type 2 diabetes) or revision bariatric surgery (for complications or side effects of a previous surgery), using a robotic approach.
干预措施: Impact of Weight on Quality of Life (IWQOL) questionnaire (Other)
Conventional laparoscopic surgical strategy
Primary bariatric surgery (According to the recommendations of the High Authority of Health: patient with a BMI ≥40 kg/m2 and/or BMI ≥35 kg/m2 associated with at least one comorbidity and/or BMI between 30 and 35 kg/m2 and suffering from type 2 diabetes) or revision bariatric surgery (for complications or side effects of a previous surgery), using a conventional laparoscopic approach.
干预措施: Conventional laparoscopic surgical strategy (Procedure)
Conventional laparoscopic surgical strategy
Primary bariatric surgery (According to the recommendations of the High Authority of Health: patient with a BMI ≥40 kg/m2 and/or BMI ≥35 kg/m2 associated with at least one comorbidity and/or BMI between 30 and 35 kg/m2 and suffering from type 2 diabetes) or revision bariatric surgery (for complications or side effects of a previous surgery), using a conventional laparoscopic approach.
干预措施: Visual analog scale (Other)
Conventional laparoscopic surgical strategy
Primary bariatric surgery (According to the recommendations of the High Authority of Health: patient with a BMI ≥40 kg/m2 and/or BMI ≥35 kg/m2 associated with at least one comorbidity and/or BMI between 30 and 35 kg/m2 and suffering from type 2 diabetes) or revision bariatric surgery (for complications or side effects of a previous surgery), using a conventional laparoscopic approach.
干预措施: EQ-5D-5L questionnaire (Other)
结局指标
主要结局
Incremental cost-effectivEness ratio (ICER)
时间窗: 1 year after surgery
Ratio expressed as additional cost per Quality Adjusted Life Year gained (cost/QALY) calculated from: * Survival and quality of life data (EQ-5D-5L questionnaire) * Cost data (micro-costing) and by individual matching with the French National Health Insurance Information System (SNDS database)
次要结局
- Number, type and severity of intraoperative complications(End of the surgery)
- Number, type and severity of postoperative complications(1, 3 and 12 months after surgery)
- Pain assessment(1 day, 2 days and 1 month after surgery)
- Reintervention rate(1, 3 and 12 months after surgery)
- Readmission rate(1, 3 and 12 months after surgery)
- Quality of life assessment with EQ-5D-5L questionnaire(Before surgery and at 1, 3, 6 and 12 months after surgery)
- Quality of life assessment with IWQOL questionnaire(Before surgery and at 1, 3, 6 and 12 months after surgery)
- Duration of surgery(End of the surgery)
- Length of hospital stay(at hospital discharge, an average of 3 days +- 2 days)
- Readmission rate in High Dependency unit and/or intensive care unit(Within 12 months after surgery)
- Cost of the initial hospital stay(at hospital discharge, an average of 3 days +- 2 days)
- ICER in subgroup of patients with preoperative BMI < 50 versus patients with preoperative BMI > 50 kg/m2(12 months after surgery)
- ICER in subgroup of patients age > 60 years old versus patients age < 60 years(12 months after surgery)
- ICER in subgroup of patients with primary surgery versus patients with revisional surgery(12 months after surgery)
- ICER in subgroup of patients with restrictive surgery versus patients with malabsorptive surgery(12 months after surgery)
- ICER depending on preoperative risk(12 months after surgery)
- Perform a budgeT impact analysis(5-year modelling)
- Weight loss(6 and 12 months after surgery)
- Changes in treatment(6 and 12 months after surgery)
- Presence of sleep apnoea syndrome(6 and 12 months after surgery)