Health-economic Assessment of Robot-assisted Bariatric Surgery (ROBOBAR)

Health Economic Impact of Robot-assisted Bariatric Surgery vs Conventional Laparoscopy: Prospective Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Procedure: Robot-assisted surgical strategy; Other: Visual analog scale; Other: EQ-5D-5L questionnaire; Other: Impact of Weight on Quality of Life (IWQOL) questionnaire; Procedure: Conventional laparoscopic surgical strategy

• Study Type: Interventional
• Enrollment (Estimated): 482
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maud ROBERT, MD, PHD; Phone Number: +33 4 72 11 62 63; Email: maud.robert@chu-lyon.fr
• Study Contact Backup: Name: Dominique DELAUNAY, MD, PHD; Phone Number: +33 4 72 11 00 64; Email: dominique.delaunay@chu-lyon.fr

Study Locations

• France
  • Bordeaux, France, 33076
    • Recruiting
    • Département de chirurgie digestive et endocrinienne Groupe Hospitalier Pellegrin Place Amélie Raba Léon 33076 BORDEAUX
    • Contact: Caroline GRONNIER, MD PhD; Phone Number: +33 5 57 65 60 05; Email: caroline.gronnier@chu-bordeaux.fr
    • Principal Investigator: Caroline GRONNIER, MD PhD
  • Dijon, France, 21000
    • Recruiting
    • Département de chirurgie digestive CHRU Dijon - Hôpital Le Bocage Bd du Maréchal de Lattre de Tassigny 21000 DIJON
    • Contact: Olivier FACY, MD PhD; Phone Number: +33 03.80.29.37.47; Email: olivier.facy@chu-dijon.Fr
    • Principal Investigator: Olivier FACY, MD PhD
  • Grenoble, France, 38043
    • Recruiting
    • Digestive Surgery Department CHU Grenoble BP217 - 38043 GRENOBLE Cedex 09
    • Contact: Fabian RECHE, MD PhD; Phone Number: +33 4 76 76 54 28; Email: FReche@chu-grenoble.fr
    • Principal Investigator: Fabian RECHE, MD PhD
  • Jossigny, France, 77600
    • 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
    • Contact: Alexandre CORTES, MD PhD; Phone Number: +33 1 61 10 71 64; Email: acortes@ghef.fr
    • Principal Investigator: Alexandre CORTES, MD PhD
  • Lille, France, 59000
    • Recruiting
    • Service de Chirurgie Générale et Endocrinienne CHU de Lille - Hôpital Claude Huriez 1 rue Michel Polonovski 59000 LILLE
    • Contact: Robert CAIAZZO, MD PhD; Phone Number: +33 3 20 44 55 16; Email: robert.caiazzo@chru-lille.fr
    • Principal Investigator: Robert CAIAZZO, MD PhD
  • Lyon, France, 69437
    • Recruiting
    • Hospices Civils de Lyon - Hôpital Edouard Herriot Chirurgie Digestive et Bariatrique 5 Place d'Arsonval - 69437 Lyon Cedex 03 - FRANCE
    • Contact: Maud ROBERT, Professor; Phone Number: +33 4 72 11 62 63; Email: maud.robert@chu-lyon.fr
    • Principal Investigator: Maud ROBERT, Professor
  • Marseille, France, 13003
    • Not yet recruiting
    • Service de Chirurgie Digestive, Hôpital Européen de Marseille, 6 rue Désirée Clary, 13003 MARSEILLE
    • Contact: Lysa MACRON, MD
    • Principal Investigator: Lysa MACRON, MD
  • Nantes, France, 44000
    • Recruiting
    • Département de chirurgie digestive et bariatrique CHU de Nantes - Site Hôtel-Dieu - HME 1 Place Alexis Ricordeau 44000 NANTES
    • Contact: Claire BLANCHARD, MD PhD; Phone Number: +33 2 40 08 33 33; Email: claire.blanchard@chu-nantes.fr
    • Principal Investigator: Claire BLANCHARD, MD PhD
  • Orléans, France, 45100
    • Recruiting
    • Département de Chirurgie digestive Hôpital de la Source CHU d'ORLEANS 14 Avenue de l'hôpital 45100 ORLEANS LA SOURCE
    • Contact: Adel ABOU-MRAD FRICQUEGNON, MD PhD; Phone Number: +33 2 38 22 95 10; Email: adel.abou-mrad@chr-orleans.fr
    • Principal Investigator: Adel ABOU-MRAD FRICQUEGNON, MD, PHD
  • Paris, France, 75013
    • 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
    • Contact: Adriana TORCIVIA, MD PhD; Phone Number: +33 1 42 17 56 44; Email: adriana.torcivia@aphp.fr
    • Principal Investigator: Adriana TORCIVIA, MD PhD
  • Paris, France, 75015
    • Recruiting
    • Département de chirurgie digestive, oncologique et bariatrique AP-HP - Hôpital Européen Georges Pompidou 20 rue Leblanc 75015 PARIS
    • Contact: Lionel REBIBO, MD PhD; Phone Number: +33 1 56 09 58 68; Email: lionel.rebibo@aphp.fr
    • Principal Investigator: Lionel REBIBO, MD PhD
  • Paris, France, 75018
    • Recruiting
    • Département de chirurgie digestive, œsogastrique et bariatrique AP-HP - Hôpital Bichat - Claude-Bernard 46 Rue Henri Huchard 75018 PARIS
    • Contact: Tigran POGHOSYAN, MD PhD; Phone Number: +33 1 40 25 82 39; Email: tigran.poghosyan@aphp.fr
    • Principal Investigator: Tigran POGHOSYAN, MD PhD
  • Poitiers, France, 86000
    • Recruiting
    • Département de chirurgie viscérale CHU de Poitiers 2 Rue de la Miletrie - CS 90577 - 86000 POITIERS
    • Contact: Jean-Pierre FAURE, MD PhD; Phone Number: +33 5.49.44.39.14; Email: jean-pierre.FAURE@chu-poitiers.fr
    • Principal Investigator: Jean-Pierre FAURE, MD PhD
  • Saint-Etienne, France, 42100
    • Recruiting
    • Clinique Chirurgicale Mutualiste 3 rue le verrier - BP 209 42100 SAINT ETIENNE
    • Contact: Pierre BLANC, MD PhD; Phone Number: +33 4 77 81 82 88; Email: PBLANC@mutualite-loire.com
    • Principal Investigator: Pierre BLANC, MD, PHD
  • Strasbourg, France, 67091
    • Recruiting
    • 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
    • Contact: Michel VIX, MD PhD; Phone Number: +33 03 69 55 13 09; Email: Michel.Vix@chru-strasbourg.fr
    • Principal Investigator: Michel VIX, MD PhD
  • Toulouse, France, 31059
    • Recruiting
    • Service de Chirurgie Digestive Hôpital Rangueil - CHU de Toulouse 1 avenue du Pr Jean Poulhès - TSA 50032 31059 TOULOUSE Cedex 9
    • Contact: Géraud TUYERAS, MD PhD; Phone Number: +33 5 61 32 34 20; Email: tuyeras.g@chu-toulouse.fr
    • Principal Investigator: Géraud TUYERAS, MD PhD
  • Vandœuvre-lès-Nancy, France, 54511
    • Recruiting
    • 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
    • Contact: Claire NOMINE-CRIQUI, MD PhD; Phone Number: +33 3 83 15 71 43; Email: c.nomine-criqui@chru-nancy.fr
    • Principal Investigator: Claire NOMINE-CRIQUI, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot-assisted surgical strategy; Primary bariatric surgery (According to the recommendations of the High Authority of Health: patient with a BMI ≥40 kg/m2 and/or BMI ≥35 kg/m2 associated with at least one comorbidity and/or BMI between 30 and 35 kg/m2 and suffering from type 2 diabetes) or revision bariatric surgery (for complications or side effects of a previous surgery), using a robotic approach.	Procedure: Robot-assisted surgical strategy; 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.; Other: Visual analog scale; All patients will have pain evaluation with visual analog scale; Other: EQ-5D-5L questionnaire; All patients will have quality of life assessment with EQ-5D-5L questionnaire; Other: Impact of Weight on Quality of Life (IWQOL) questionnaire; All patients will have Quality of life assessment with IWQOL questionnaire
Active Comparator: Conventional laparoscopic surgical strategy; Primary bariatric surgery (According to the recommendations of the High Authority of Health: patient with a BMI ≥40 kg/m2 and/or BMI ≥35 kg/m2 associated with at least one comorbidity and/or BMI between 30 and 35 kg/m2 and suffering from type 2 diabetes) or revision bariatric surgery (for complications or side effects of a previous surgery), using a conventional laparoscopic approach.	Other: Visual analog scale; All patients will have pain evaluation with visual analog scale; Other: EQ-5D-5L questionnaire; All patients will have quality of life assessment with EQ-5D-5L questionnaire; Other: Impact of Weight on Quality of Life (IWQOL) questionnaire; All patients will have Quality of life assessment with IWQOL questionnaire; Procedure: Conventional laparoscopic surgical strategy; Primary or revision bariatric surgery (for complications or side effects of a previous surgery), using a conventional laparoscopic approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental cost-effectivEness ratio (ICER)	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)	1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number, type and severity of intraoperative complications	Number, type (medical or surgical) and severity of intraoperative complications (during surgery) for each procedure according to the Dindo-Clavien classification.	End of the surgery
Number, type and severity of postoperative complications	Number, type (medical or surgical) and severity of complications (within 1 year after surgery) for each procedure according to the Dindo-Clavien classification	1, 3 and 12 months after surgery
Pain assessment	Pain will be assessed 1 day, 2 days and 1 month after surgery, according to a visual analogic scale (VAS). The VAS measures the intensity of pain on a scale from 0 to 10. 0 representing no pain and at the opposite end, 10 representing extreme pain	1 day, 2 days and 1 month after surgery
Readmission rate	Number of patients readmitted within 1 year after surgery.	1, 3 and 12 months after surgery
Reintervention rate	Number of patients for whom reintervention was necessary within 1 year after surgery.	1, 3 and 12 months after surgery
Quality of life assessment with EQ-5D-5L questionnaire	This questionnaire is divided into 2 parts: A first part with the questions called "EQ-5D descriptive system", representing 5 dimensions: Mobility, Personal autonomy, Current activities, Pain and discomfort, Anxiety and depression. The response is based on 5-point scales (1: no problem; 2: mild problems; 3: moderate problems; 4: severe problems; 5: extreme problems or total incapacity). This part is completed by a visual analog scale, called "EQ-5D VAS". It consists of a 20 cm line, graduated from 0 to 100, where the patient must indicate how they evaluate their current state of health, 0 being the worst possible state and 100 the best	Before surgery and at 1, 3, 6 and 12 months after surgery
Quality of life assessment with IWQOL questionnaire	This questionnaire includes five health concepts: mobility, self-esteem, social life, working conditions and sex life. Five answers will be offered to patients for each item and each answer will be assigned a score ranging from 1 to 5. The most pejorative score is 155.	Before surgery and at 1, 3, 6 and 12 months after surgery
Duration of surgery	Operative time expressed in minutes	End of the surgery
Length of hospital stay	The Length of stay (in days) is based on the number of days of hospitalization from surgery (day of surgery = D0) until the day of discharge	at hospital discharge, an average of 3 days +- 2 days
Readmission rate in High Dependency unit and/or intensive care unit	Number of patients for whom readmission rate in High Dependency unit and/or intensive care unit was necessary within 1 years after surgery.	Within 12 months after surgery
Cost of the initial hospital stay	the cost of the initial surgical stay for each group will be calculated using the micro-costing method	at hospital discharge, an average of 3 days +- 2 days
ICER in subgroup of patients with preoperative BMI < 50 versus patients with preoperative BMI > 50 kg/m2	Ratio expressed as additional cost per Quality Adjusted Life Year gained (cost/QALY)	12 months after surgery
ICER in subgroup of patients age > 60 years old versus patients age < 60 years	Ratio expressed as additional cost per Quality Adjusted Life Year gained (cost/QALY)	12 months after surgery
ICER in subgroup of patients with primary surgery versus patients with revisional surgery	Ratio expressed as additional cost per Quality Adjusted Life Year gained (cost/QALY)	12 months after surgery
ICER in subgroup of patients with restrictive surgery versus patients with malabsorptive surgery	Ratio expressed as additional cost per Quality Adjusted Life Year gained (cost/QALY)	12 months after surgery
ICER depending on preoperative risk	Ratio expressed as additional cost per Quality Adjusted Life Year gained (cost/QALY)	12 months after surgery
Perform a budgeT impact analysis	Financial consequences of adopting robotic from the perspective of the French public health care system at 5 years	5-year modelling
Weight loss	Weight loss at 6 and 12 months expressed as an absolute value (aWL in kg), as a percentage of total weight loss (%TWL; [(Weight at each visit - initial weight) / (initial weight)] × 100), as a percentage of excess weight loss (%EWL; [(Weight at each visit - baseline weight) / (baseline weight - ideal weight)] × 100); as a percentage of excess BMI loss (%BMI; [(BMI at each visit - baseline BMI) / (baseline BMI - ideal BMI)] × 100, using 25 as the ideal BMI).	6 and 12 months after surgery
Changes in treatment	Changes in treatment with antidiabetic, antihypertensive, lipid-lowering and gastro-oesophageal reflux medications	6 and 12 months after surgery
Presence of sleep apnoea syndrome	Assessment of the presence of sleep apnoea syndrome 6 and 12 months after surgery.	6 and 12 months after surgery

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Bariatric surgery; Robot
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 69HCL24_0757

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No