TrialGlobe

Clinical trial

Health-economic Assessment of Robot-assisted Bariatric Surgery

Recruiting now · Not applicable · 1 countries · Registry ID NCT06858761

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry 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

Treatments and study arms

Robot-assisted surgical strategy

Procedure

Primary or revision bariatric surgery (for complications or side effects of a previous surgery), using a robotic approach. The robot used will be the Da Vinci X or Xi model (depending on the center) from the company Intuitive Surgical.

Conventional laparoscopic surgical strategy

Procedure

Primary or revision bariatric surgery (for complications or side effects of a previous surgery), using a conventional laparoscopic approach

Visual analog scale

Other

All patients will have pain evaluation with visual analog scale

EQ-5D-5L questionnaire

Other

All patients will have quality of life assessment with EQ-5D-5L questionnaire

Impact of Weight on Quality of Life (IWQOL) questionnaire

Other

All patients will have Quality of life assessment with IWQOL questionnaire

Primary outcomes

Incremental cost-effectivEness ratio (ICER)1 year after surgery

Ratio expressed as additional cost per Quality Adjusted Life Year gained (cost/QALY) calculated from: * Survival and quality of life data (EQ-5D-5L questionnaire) * Cost data (micro-costing) and by individual matching with the French National Health Insurance Information System (SNDS database)

Study locations

18 locations were listed when this page was built. The first 40 are shown.

Département de chirurgie digestive et endocrinienne Groupe Hospitalier Pellegrin Place Amélie Raba Léon 33076 BORDEAUX🇫🇷 Bordeaux, France
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Caroline GRONNIER, MD PhDContact
Email · Call +33 5 57 65 60 05
Caroline GRONNIER, MD PhDPrincipal Investigator
Département de chirurgie digestive CHRU Dijon - Hôpital Le Bocage Bd du Maréchal de Lattre de Tassigny 21000 DIJON🇫🇷 Dijon, France
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Olivier FACY, MD PhDContact
Email · Call +33 03.80.29.37.47
Olivier FACY, MD PhDPrincipal Investigator
Digestive Surgery Department CHU Grenoble BP217 - 38043 GRENOBLE Cedex 09🇫🇷 Grenoble, France
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Fabian RECHE, MD PhDContact
Email · Call +33 4 76 76 54 28
Fabian RECHE, MD PhDPrincipal Investigator
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
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Alexandre CORTES, MD PhDContact
Email · Call +33 1 61 10 71 64
Alexandre CORTES, MD PhDPrincipal Investigator
Service de Chirurgie Générale et Endocrinienne CHU de Lille - Hôpital Claude Huriez 1 rue Michel Polonovski 59000 LILLE🇫🇷 Lille, France
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Robert CAIAZZO, MD PhDContact
Email · Call +33 3 20 44 55 16
Robert CAIAZZO, MD PhDPrincipal Investigator
Hospices Civils de Lyon - Hôpital Edouard Herriot Chirurgie Digestive et Bariatrique 5 Place d'Arsonval - 69437 Lyon Cedex 03 - FRANCE🇫🇷 Lyon, France
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Maud ROBERT, ProfessorContact
Email · Call +33 4 72 11 62 63
Maud ROBERT, ProfessorPrincipal Investigator
Service de Chirurgie Digestive, Hôpital Européen de Marseille, 6 rue Désirée Clary, 13003 MARSEILLE🇫🇷 Marseille, France
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Lysa MACRON, MDContact
Lysa MACRON, MDPrincipal Investigator
Département de chirurgie digestive et bariatrique CHU de Nantes - Site Hôtel-Dieu - HME 1 Place Alexis Ricordeau 44000 NANTES🇫🇷 Nantes, France
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Claire BLANCHARD, MD PhDContact
Email · Call +33 2 40 08 33 33
Claire BLANCHARD, MD PhDPrincipal Investigator
Service de Chirurgie Digestive et Transplantation Hépatique, Hôpital de l'Archet 2, CHU de Nice🇫🇷 Nice, France
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Imed BEN AMOR, MDContact
Imed BEN AMOR, MDPrincipal Investigator
Département de Chirurgie digestive Hôpital de la Source CHU d'ORLEANS 14 Avenue de l'hôpital 45100 ORLEANS LA SOURCE🇫🇷 Orléans, France
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Adel ABOU-MRAD FRICQUEGNON, MD PhDContact
Email · Call +33 2 38 22 95 10
Adel ABOU-MRAD FRICQUEGNON, MD, PHDPrincipal Investigator
Département de chirurgie digestive, oncologique et bariatrique AP-HP - Hôpital Européen Georges Pompidou 20 rue Leblanc 75015 PARIS🇫🇷 Paris, France
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Lionel REBIBO, MD PhDContact
Email · Call +33 1 56 09 58 68
Lionel REBIBO, MD PhDPrincipal Investigator
Département de chirurgie digestive, œsogastrique et bariatrique AP-HP - Hôpital Bichat - Claude-Bernard 46 Rue Henri Huchard 75018 PARIS🇫🇷 Paris, France
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Tigran POGHOSYAN, MD PhDContact
Email · Call +33 1 40 25 82 39
Tigran POGHOSYAN, MD PhDPrincipal Investigator
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
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Adriana TORCIVIA, MD PhDContact
Email · Call +33 1 42 17 56 44
Adriana TORCIVIA, MD PhDPrincipal Investigator
Département de chirurgie viscérale CHU de Poitiers 2 Rue de la Miletrie - CS 90577 - 86000 POITIERS🇫🇷 Poitiers, France
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Jean-Pierre FAURE, MD PhDContact
Email · Call +33 5.49.44.39.14
Jean-Pierre FAURE, MD PhDPrincipal Investigator
Clinique Chirurgicale Mutualiste 3 rue le verrier - BP 209 42100 SAINT ETIENNE🇫🇷 Saint-Etienne, France
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Pierre BLANC, MD PhDContact
Email · Call +33 4 77 81 82 88
Pierre BLANC, MD, PHDPrincipal Investigator
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
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Elisa REITANO, MDContact
Elisa REITANO, MDPrincipal Investigator
Service de Chirurgie Digestive Hôpital Rangueil - CHU de Toulouse 1 avenue du Pr Jean Poulhès - TSA 50032 31059 TOULOUSE Cedex 9🇫🇷 Toulouse, France
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Géraud TUYERAS, MD PhDContact
Email · Call +33 5 61 32 34 20
Géraud TUYERAS, MD PhDPrincipal Investigator
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
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Claire NOMINE-CRIQUI, MD PhDContact
Email · Call +33 3 83 15 71 43
Claire NOMINE-CRIQUI, MD PhDPrincipal Investigator