Health-economic Assessment of Robot-assisted Bariatric Surgery

Hospices Civils de Lyon482 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Interventions

Robot-assisted surgical strategyPROCEDURE

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.

Conventional laparoscopic surgical strategyPROCEDURE

Primary or revision bariatric surgery (for complications or side effects of a previous surgery), using a conventional laparoscopic approach

Visual analog scaleOTHER

All patients will have pain evaluation with visual analog scale

EQ-5D-5L questionnaireOTHER

All patients will have quality of life assessment with EQ-5D-5L questionnaire

Impact of Weight on Quality of Life (IWQOL) questionnaireOTHER

All patients will have Quality of life assessment with IWQOL questionnaire

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (18)

Département de chirurgie digestive et endocrinienne Groupe Hospitalier Pellegrin Place Amélie Raba Léon 33076 BORDEAUX

Bordeaux, France

RECRUITING

Département de chirurgie digestive CHRU Dijon - Hôpital Le Bocage Bd du Maréchal de Lattre de Tassigny 21000 DIJON

Dijon, France

RECRUITING

Digestive Surgery Department CHU Grenoble BP217 - 38043 GRENOBLE Cedex 09

Grenoble, France

RECRUITING

Service de Chirurgie Générale et Digestive Grand Hopital de l'Est Francilien Site de Marne La Vallée 2-4 Cours de la Gondoire 77600 JOSSIGNY

Outcomes

Primary Outcomes

Incremental cost-effectivEness ratio (ICER)

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)

Time frame: 1 year after surgery

Secondary Outcomes

Number, type and severity of intraoperative complications

Number, type (medical or surgical) and severity of intraoperative complications (during surgery) for each procedure according to the Dindo-Clavien classification.

Time frame: End of the surgery

Number, type and severity of postoperative complications

Number, type (medical or surgical) and severity of complications (within 1 year after surgery) for each procedure according to the Dindo-Clavien classification

Time frame: 1, 3 and 12 months after surgery

Pain assessment

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

Time frame: 1 day, 2 days and 1 month after surgery

Readmission rate

Number of patients readmitted within 1 year after surgery.

Time frame: 1, 3 and 12 months after surgery

Reintervention rate

Number of patients for whom reintervention was necessary within 1 year after surgery.

Time frame: 1, 3 and 12 months after surgery

Quality of life assessment with EQ-5D-5L questionnaire

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

Time frame: Before surgery and at 1, 3, 6 and 12 months after surgery

Quality of life assessment with IWQOL questionnaire

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.

Time frame: Before surgery and at 1, 3, 6 and 12 months after surgery

Duration of surgery

Operative time expressed in minutes

Time frame: End of the surgery

Length of hospital stay

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

Time frame: at hospital discharge, an average of 3 days +- 2 days

Readmission rate in High Dependency unit and/or intensive care unit

Number of patients for whom readmission rate in High Dependency unit and/or intensive care unit was necessary within 1 years after surgery.

Time frame: Within 12 months after surgery

Cost of the initial hospital stay

the cost of the initial surgical stay for each group will be calculated using the micro-costing method

Time frame: 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