Health-economic Assessment of Robot-assisted Bariatric Surgery (ROBOBAR)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Obesity

Treatments: Other: EQ-5D-5L questionnaire; Procedure: Conventional laparoscopic surgical strategy; Other: Visual analog scale; Procedure: Robot-assisted surgical strategy; Other: Impact of Weight on Quality of Life (IWQOL) questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT06858761

69HCL24_0757

Details and patient eligibility

About

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.

Enrollment: 482 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

482 participants in 2 patient groups

Robot-assisted surgical strategy

Experimental group

Description:

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.

Treatment:

Other: Impact of Weight on Quality of Life (IWQOL) questionnaire

Procedure: Robot-assisted surgical strategy

Other: Visual analog scale

Other: EQ-5D-5L questionnaire

Conventional laparoscopic surgical strategy

Active Comparator group

Description:

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.

Treatment:

Other: Impact of Weight on Quality of Life (IWQOL) questionnaire

Other: Visual analog scale

Procedure: Conventional laparoscopic surgical strategy

Other: EQ-5D-5L questionnaire