Condition: Obesity · Sponsor: Hospices Civils de Lyon
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 c…
This description comes directly from the study's public registry record.
Maud ROBERT, MD, PHD · +33 4 72 11 62 63 · maud.robert@chu-lyon.fr
Dominique DELAUNAY, MD, PHD · +33 4 72 11 00 64 · dominique.delaunay@chu-lyon.fr
Always discuss trial participation with your own doctor first.
| 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 |
| Service de Chirurgie Digestive, Hôpital Européen de Marseille, 6 rue Désirée Clary, 13003 MARSEILLE | Marseille, France | Recruiting |
| Département de chirurgie digestive et bariatrique CHU de Nantes - Site Hôtel-Dieu - HME 1 Place Alexis Ricordeau 44000 NANTES | Nantes, France | Recruiting |
| Service de Chirurgie Digestive et Transplantation Hépatique, Hôpital de l'Archet 2, CHU de Nice | Nice, France | Not Yet Recruiting |
| Département de Chirurgie digestive Hôpital de la Source CHU d'ORLEANS 14 Avenue de l'hôpital 45100 ORLEANS LA SOURCE | Orléans, France | Recruiting |
| Service de Chirurgie Digestive Hépato-bilio-pancréatique et Transplantation Hépatique Chirurgie Bariatrique, coelioscopique et robotique AP-HP - Hôpital Universitaire La Pitié Salpêtrière 47-83 boulevard de l'hôpital 75013 PARIS | Paris, France | Recruiting |
| Département de chirurgie digestive, oncologique et bariatrique AP-HP - Hôpital Européen Georges Pompidou 20 rue Leblanc 75015 PARIS | Paris, France | Recruiting |
+ 6 more locations — full list on the registry record.
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