Actively Recruiting
Health-economic Assessment of Robot-assisted Bariatric Surgery
Led by Hospices Civils de Lyon · Updated on 2026-04-03
482
Participants Needed
17
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 consumption. The quality of life will be assessed using the EuroQol-5 Dimension (EQ5D-5L) questionnaire. PERSPECTIVES: This study will have a direct impact on patients care, professional practices and public health policy either by validating the value of the robot in bariatric surgery or conversely, by promoting the laparoscopic approach. HYPOTHESIS : Robot-assisted bariatric surgery is more expensive than conventional laparoscopy, but the additional costs associated with the robot are partly offset by a reduction in post-operative complications at 1 year, which should also help to improve patients' quality of life.
CONDITIONS
Official Title
Health-economic Assessment of Robot-assisted Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged between 18 and 70 years old
- Female or male patients
- Eligible for primary bariatric or metabolic surgery with BMI 40 kg/m2 or BMI 35 kg/m2 with at least one comorbidity that may improve after surgery, or BMI between 30 and 35 kg/m2 with uncontrolled type 2 diabetes
- Eligible for revision surgery for complications or side effects of previous bariatric surgery
- Patient evaluated by a multidisciplinary team (medical, surgical, psychiatric) with favorable opinion for bariatric surgery
- Patient agrees to participate and signs informed consent form
You will not qualify if you...
- Presence of a severe and life-threatening disease unrelated to obesity
- Pregnancy or desire to be pregnant during the study
- Not affiliated with French or European healthcare insurance
- Under supervision or guardianship
- Unable to give consent
- Does not understand French
- Previously included in a conflicting clinical trial
AI-Screening
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Trial Site Locations
Total: 17 locations
1
Département de chirurgie digestive et endocrinienne Groupe Hospitalier Pellegrin Place Amélie Raba Léon 33076 BORDEAUX
Bordeaux, France, 33076
Actively Recruiting
2
Département de chirurgie digestive CHRU Dijon - Hôpital Le Bocage Bd du Maréchal de Lattre de Tassigny 21000 DIJON
Dijon, France, 21000
Actively Recruiting
3
Digestive Surgery Department CHU Grenoble BP217 - 38043 GRENOBLE Cedex 09
Grenoble, France, 38043
Actively Recruiting
4
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, 77600
Actively Recruiting
5
Service de Chirurgie Générale et Endocrinienne CHU de Lille - Hôpital Claude Huriez 1 rue Michel Polonovski 59000 LILLE
Lille, France, 59000
Actively Recruiting
6
Hospices Civils de Lyon - Hôpital Edouard Herriot Chirurgie Digestive et Bariatrique 5 Place d'Arsonval - 69437 Lyon Cedex 03 - FRANCE
Lyon, France, 69437
Actively Recruiting
7
Service de Chirurgie Digestive, Hôpital Européen de Marseille, 6 rue Désirée Clary, 13003 MARSEILLE
Marseille, France, 13003
Not Yet Recruiting
8
Département de chirurgie digestive et bariatrique CHU de Nantes - Site Hôtel-Dieu - HME 1 Place Alexis Ricordeau 44000 NANTES
Nantes, France, 44000
Actively Recruiting
9
Département de Chirurgie digestive Hôpital de la Source CHU d'ORLEANS 14 Avenue de l'hôpital 45100 ORLEANS LA SOURCE
Orléans, France, 45100
Actively Recruiting
10
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, 75013
Actively Recruiting
11
Département de chirurgie digestive, oncologique et bariatrique AP-HP - Hôpital Européen Georges Pompidou 20 rue Leblanc 75015 PARIS
Paris, France, 75015
Actively Recruiting
12
Département de chirurgie digestive, œsogastrique et bariatrique AP-HP - Hôpital Bichat - Claude-Bernard 46 Rue Henri Huchard 75018 PARIS
Paris, France, 75018
Actively Recruiting
13
Département de chirurgie viscérale CHU de Poitiers 2 Rue de la Miletrie - CS 90577 - 86000 POITIERS
Poitiers, France, 86000
Actively Recruiting
14
Clinique Chirurgicale Mutualiste 3 rue le verrier - BP 209 42100 SAINT ETIENNE
Saint-Etienne, France, 42100
Actively Recruiting
15
Département de chirurgie digestive et endocrinienne CHU de Strasbourg - Nouvel Hôpital civil Rez-de-chaussée 1 place de l'hôpital BP 426 67091 STRASBOURG cedex
Strasbourg, France, 67091
Actively Recruiting
16
Service de Chirurgie Digestive Hôpital Rangueil - CHU de Toulouse 1 avenue du Pr Jean Poulhès - TSA 50032 31059 TOULOUSE Cedex 9
Toulouse, France, 31059
Actively Recruiting
17
Département de Chirurgie Viscérale Métabolique et Cancérologique Responsable de l'Unité de Chirurgie Endocrinienne Université de Lorraine CHRU de Nancy - Hôpital Brabois adultes 11 allée du Morvan 54511 VANDOEUVRE LES NANCY
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
Research Team
M
Maud ROBERT, MD, PHD
CONTACT
D
Dominique DELAUNAY, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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