Obesity
Conditions
Keywords
Obesity, Bariatric surgery, Robot
Brief summary
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.
Interventions
PROCEDURERobot-assisted surgical strategy
Primary or revision bariatric surgery (for complications or side effects of a previous surgery), using a robotic approach. The robot used will be the Da Vinci X or Xi model (depending on the center) from the company Intuitive Surgical.
PROCEDUREConventional laparoscopic surgical strategy
Primary or revision bariatric surgery (for complications or side effects of a previous surgery), using a conventional laparoscopic approach
OTHERVisual analog scale
All patients will have pain evaluation with visual analog scale
All patients will have quality of life assessment with EQ-5D-5L questionnaire
OTHERImpact of Weight on Quality of Life (IWQOL) questionnaire
All patients will have Quality of life assessment with IWQOL questionnaire
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
Single-blind study: patient will not be informed of the approach (laparoscopic or robotic) which will be used for their intervention.
Intervention model description
Prospective multicenter randomized, controlled in 2 parallel groups, single-blind, superiority trial comparing 2 modalities of bariatric surgery (first-line or revision): * Robotic surgical strategy * Conventional laparoscopic surgical strategy
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient aged between 18 and 70 years old, * Female or male patients * Patient eligible for one of the two situations defined below: 1. 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 2. 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,
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incremental cost-effectivEness ratio (ICER) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number, type and severity of intraoperative complications | End of the surgery | Number, type (medical or surgical) and severity of intraoperative complications (during surgery) for each procedure according to the Dindo-Clavien classification. |
| Number, type and severity of postoperative complications | 1, 3 and 12 months after surgery | Number, type (medical or surgical) and severity of complications (within 1 year after surgery) for each procedure according to the Dindo-Clavien classification |
| Pain assessment | 1 day, 2 days and 1 month after surgery | Pain will be assessed 1 day, 2 days and 1 month after surgery, according to a visual analogic scale (VAS). The VAS measures the intensity of pain on a scale from 0 to 10. 0 representing no pain and at the opposite end, 10 representing extreme pain |
| Readmission rate | 1, 3 and 12 months after surgery | Number of patients readmitted within 1 year after surgery. |
| Reintervention rate | 1, 3 and 12 months after surgery | Number of patients for whom reintervention was necessary within 1 year after surgery. |
| Quality of life assessment with EQ-5D-5L questionnaire | Before surgery and at 1, 3, 6 and 12 months after surgery | This questionnaire is divided into 2 parts: A first part with the questions called "EQ-5D descriptive system", representing 5 dimensions: Mobility, Personal autonomy, Current activities, Pain and discomfort, Anxiety and depression. The response is based on 5-point scales (1: no problem; 2: mild problems; 3: moderate problems; 4: severe problems; 5: extreme problems or total incapacity). This part is completed by a visual analog scale, called "EQ-5D VAS". It consists of a 20 cm line, graduated from 0 to 100, where the patient must indicate how they evaluate their current state of health, 0 being the worst possible state and 100 the best |
| Quality of life assessment with IWQOL questionnaire | Before surgery and at 1, 3, 6 and 12 months after surgery | This questionnaire includes five health concepts: mobility, self-esteem, social life, working conditions and sex life. Five answers will be offered to patients for each item and each answer will be assigned a score ranging from 1 to 5. The most pejorative score is 155. |
| Duration of surgery | End of the surgery | Operative time expressed in minutes |
| Length of hospital stay | at hospital discharge, an average of 3 days +- 2 days | The Length of stay (in days) is based on the number of days of hospitalization from surgery (day of surgery = D0) until the day of discharge |
| Readmission rate in High Dependency unit and/or intensive care unit | Within 12 months after surgery | Number of patients for whom readmission rate in High Dependency unit and/or intensive care unit was necessary within 1 years after surgery. |
| Cost of the initial hospital stay | at hospital discharge, an average of 3 days +- 2 days | the cost of the initial surgical stay for each group will be calculated using the micro-costing method |
| ICER in subgroup of patients with preoperative BMI < 50 versus patients with preoperative BMI > 50 kg/m2 | 12 months after surgery | Ratio expressed as additional cost per Quality Adjusted Life Year gained (cost/QALY) |
| ICER in subgroup of patients age > 60 years old versus patients age < 60 years | 12 months after surgery | Ratio expressed as additional cost per Quality Adjusted Life Year gained (cost/QALY) |
| ICER in subgroup of patients with primary surgery versus patients with revisional surgery | 12 months after surgery | Ratio expressed as additional cost per Quality Adjusted Life Year gained (cost/QALY) |
| ICER in subgroup of patients with restrictive surgery versus patients with malabsorptive surgery | 12 months after surgery | Ratio expressed as additional cost per Quality Adjusted Life Year gained (cost/QALY) |
| ICER depending on preoperative risk | 12 months after surgery | Ratio expressed as additional cost per Quality Adjusted Life Year gained (cost/QALY) |
| Perform a budgeT impact analysis | 5-year modelling | Financial consequences of adopting robotic from the perspective of the French public health care system at 5 years |
| Weight loss | 6 and 12 months after surgery | Weight loss at 6 and 12 months expressed as an absolute value (aWL in kg), as a percentage of total weight loss (%TWL; \[(Weight at each visit - initial weight) / (initial weight)\] × 100), as a percentage of excess weight loss (%EWL; \[(Weight at each visit - baseline weight) / (baseline weight - ideal weight)\] × 100); as a percentage of excess BMI loss (%BMI; \[(BMI at each visit - baseline BMI) / (baseline BMI - ideal BMI)\] × 100, using 25 as the ideal BMI). |
| Changes in treatment | 6 and 12 months after surgery | Changes in treatment with antidiabetic, antihypertensive, lipid-lowering and gastro-oesophageal reflux medications |
| Presence of sleep apnoea syndrome | 6 and 12 months after surgery | Assessment of the presence of sleep apnoea syndrome 6 and 12 months after surgery. |
Countries
France
Contacts
CONTACTMaud ROBERT, MD, PHD
CONTACTDominique DELAUNAY, MD, PHD
Outcome results
None listed