Comparing robotic and laparoscopic approaches for bariatric surgery costs and outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
  Jossigny, France Recruiting
• Service de Chirurgie Générale et Endocrinienne CHU de Lille - Hôpital Claude Huriez 1 rue Michel Polonovski 59000 LILLE
  Lille, France Recruiting
• Hospices Civils de Lyon - Hôpital Edouard Herriot Chirurgie Digestive et Bariatrique 5 Place d'Arsonval - 69437 Lyon Cedex 03 - FRANCE
  Lyon, France Recruiting

Study contacts

• Study coordinator: Maud ROBERT, MD, PHD
• Email: maud.robert@chu-lyon.fr
• Phone: +33 4 72 11 62 63

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ocular Changes in People Using Tirzepatide or Semaglutide

  This study checks whether eye structure and blood vessels change in adults with obesity who are taking semaglutide or tirzepatide as part of routine care.

  Recruiting Istanbul University · Istanbul, Istanbul · NCT07924618

• Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes

  This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.

  Recruiting Pamukkale University · Denizli · NCT07924436

• Berobenatide for knee pain in adults who are overweight or with obesity

  This study tests berobenatide vs. placebo to see if it reduces knee pain and improves function while helping with weight in adults with knee osteoarthritis and overweight/obesity.

  Recruiting at 7 sites Phase 3 Pfizer · Tempe, Arizona and 39 other locations · NCT07919678

• Weekly berobenatide for knee osteoarthritis in adults who are overweight or obese

  This study tests whether weekly berobenatide helps reduce knee pain and improve function, while also affecting body weight, in adults with knee osteoarthritis who are overweight or obese (with or without type 2 diabetes).

  Recruiting Phase 3 Pfizer · Birmingham, Alabama and 3 other locations · NCT07915609

• Maridebart cafraglutide in people who switched from weekly GLP-1 receptor agonists

  This study tests how much maridebart cafraglutide appears in the blood after people with overweight or obesity switch from weekly GLP-1 receptor agonists.

  Recruiting at 9 sites Phase 1 Amgen · Phoenix, Arizona and 8 other locations · NCT07908316

• EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes

  This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.

  Recruiting Phase 3 Eli Lilly and Company · Tucson, Arizona and 74 other locations · NCT07881458

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.