Home › Trials › NCT06858761

Comparing robotic and laparoscopic approaches for bariatric surgery costs and outcomes

Health Economic Impact of Robot-assisted Bariatric Surgery vs Conventional Laparoscopy: Prospective Multicenter Randomized Controlled Trial

Not applicable Interventional Hospices Civils de Lyon · NCT06858761

This project will test whether robot-assisted bariatric surgery gives adults eligible for primary or revision bariatric procedures better quality-of-life outcomes that justify its higher cost.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment482 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorHospices Civils de Lyon Academic / other
Locations17 sites (Bordeaux and 16 other locations)
Trial IDNCT06858761 on ClinicalTrials.gov

What this trial studies

This interventional health-economic project compares robot-assisted versus conventional laparoscopic bariatric surgery in adults meeting French guideline criteria for primary or revision operations. Investigators will collect clinical outcomes, complication rates, patient-reported health status (EQ-5D-5L, IWQOL, visual analog scales) and resource use to calculate cost per quality-adjusted life-year (QALY) gained. The analysis will combine clinical follow-up and economic data to derive a cost-effectiveness ratio for the Da Vinci robotic platform. The work is conducted across multiple French academic surgical centers.

Who should consider this trial

Good fit: Adults aged 18–70 who meet French HAS BMI and comorbidity criteria for primary bariatric surgery or who require revision surgery, and who have a favorable multidisciplinary evaluation, are eligible.

Not a fit: People who do not meet the BMI/comorbidity criteria, have contraindications to bariatric surgery, or are not candidates for either robotic or laparoscopic approaches are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could show whether the robotic approach delivers enough additional quality-adjusted life years to justify its higher costs, informing surgical practice and funding decisions.

How similar studies have performed: Robotic platforms have shown clear advantages in some procedures like prostatectomy and rectal surgery, but evidence in bariatric surgery is mixed with limited data suggesting benefit mainly for complex or selected cases.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Bordeaux and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ObesityBariatric surgeryRobot
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.