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Health-economic Assessment of Robot-assisted Bariatric Surgery

RecruitingNAAges 18 Years - 70 YearsAllHospices Civils de Lyon
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In plain words

What the trial is, and whether it could suit you

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 expresse

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📋 Eligibility rules (as published)
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
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What it tests

  • Robot-assisted surgical strategy
  • Conventional laparoscopic surgical strategy
  • Visual analog scale
  • EQ-5D-5L questionnaire
  • Impact of Weight on Quality of Life (IWQOL) questionnaire
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Where

18 sites
Département de chirurgie digestive et endocrinienne Groupe Hospitalier Pellegrin Place Amélie Raba Léon 33076 BORDEAUX
Bordeaux, France
Département de chirurgie digestive CHRU Dijon - Hôpital Le Bocage Bd du Maréchal de Lattre de Tassigny 21000 DIJON
Dijon, France
Digestive Surgery Department CHU Grenoble BP217 - 38043 GRENOBLE Cedex 09
Grenoble, France
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
Service de Chirurgie Générale et Endocrinienne CHU de Lille - Hôpital Claude Huriez 1 rue Michel Polonovski 59000 LILLE
Lille, France
Hospices Civils de Lyon - Hôpital Edouard Herriot Chirurgie Digestive et Bariatrique 5 Place d'Arsonval - 69437 Lyon Cedex 03 - FRANCE
Lyon, France
Service de Chirurgie Digestive, Hôpital Européen de Marseille, 6 rue Désirée Clary, 13003 MARSEILLE
Marseille, France
Département de chirurgie digestive et bariatrique CHU de Nantes - Site Hôtel-Dieu - HME 1 Place Alexis Ricordeau 44000 NANTES
Nantes, France

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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