Health-economic Assessment of Robot-assisted Bariatric Surgery

Launched by HOSPICES CIVILS DE LYON · Feb 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a robotic approach to bariatric surgery, which is a type of weight-loss surgery for people with obesity. The goal is to find out if using the Da Vinci robot during surgery is cost-effective compared to traditional laparoscopic surgery (a less invasive technique using small incisions). Researchers will look at the costs related to both methods and how they impact patients' quality of life one year after surgery.

To participate in this study, you need to be between 18 and 70 years old and have a body mass index (BMI) that meets specific criteria for obesity, or require surgery to address complications from a previous weight-loss surgery. Eligible participants will undergo a thorough evaluation by a team of healthcare professionals and will need to provide consent to join the study. Throughout the trial, participants can expect regular assessments of their health and quality of life. This research will help determine if robotic surgery is worthwhile for patients and healthcare systems or if the traditional laparoscopic method is still the better option.

Gender

ALL

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