NCT06858761 Health-economic Assessment of Robot-assisted Bariatric Surgery
| NCT ID | NCT06858761 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 482 participants |
| Start Date | 2025-07-25 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 482 participants in total. It began in 2025-07-25 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06858761 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06858761 currently recruiting?
Yes, NCT06858761 is actively recruiting participants. Contact the research team at maud.robert@chu-lyon.fr for enrollment information.
Where is the NCT06858761 trial being conducted?
This trial is being conducted at Bordeaux, France, Dijon, France, Grenoble, France, Jossigny, France and 11 additional locations.
Who is sponsoring the NCT06858761 clinical trial?
NCT06858761 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 482 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.