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ObesityROBOBARNCT06858761

Health-economic Assessment of Robot-assisted Bariatric Surgery

A study testing Robot-assisted surgical strategy, Conventional laparoscopic surgical strategy and Visual analog scale in people with Obesity, run by Hospices Civils de Lyon at 18 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Obesity
What is being tested?
Robot-assisted surgical strategy, Conventional laparoscopic surgical strategy and Visual analog scale
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
482 participants
Where
18 sitesFrance
Study dates
25 Jul 2025to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient aged between 18 and 70 years old,
  • Female or male patients
  • Patient eligible for one of the two situations defined below:
  • 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
Show all 9Show fewer
  • 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,

Who cannot join

  • 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

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maud ROBERT, MD, PHD contact

+33 4 72 11 62 63

maud.robert@chu-lyon.fr

Dominique DELAUNAY, MD, PHD contact

+33 4 72 11 00 64

dominique.delaunay@chu-lyon.fr

18 sites in 1 country

France18 sites, 18 recruiting

  • Département de chirurgie digestive et endocrinienne Groupe Hospitalier Pellegrin Place Amélie Raba Léon 33076 BORDEAUX

    Bordeaux, 33076

    Caroline GRONNIER, MD PhD, +33 5 57 65 60 05, caroline.gronnier@chu-bordeaux.fr

    Caroline GRONNIER, MD PhD

    Recruiting

  • Département de chirurgie digestive CHRU Dijon - Hôpital Le Bocage Bd du Maréchal de Lattre de Tassigny 21000 DIJON

    Dijon, 21000

    Olivier FACY, MD PhD, +33 03.80.29.37.47, olivier.facy@chu-dijon.Fr

    Olivier FACY, MD PhD

    Recruiting

  • Digestive Surgery Department CHU Grenoble BP217 - 38043 GRENOBLE Cedex 09

    Grenoble, 38043

    Fabian RECHE, MD PhD, +33 4 76 76 54 28, FReche@chu-grenoble.fr

    Fabian RECHE, MD PhD

    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, 77600

    Alexandre CORTES, MD PhD, +33 1 61 10 71 64, acortes@ghef.fr

    Alexandre CORTES, MD PhD

    Recruiting

  • Service de Chirurgie Générale et Endocrinienne CHU de Lille - Hôpital Claude Huriez 1 rue Michel Polonovski 59000 LILLE

    Lille, 59000

    Robert CAIAZZO, MD PhD, +33 3 20 44 55 16, robert.caiazzo@chru-lille.fr

    Robert CAIAZZO, MD PhD

    Recruiting

  • Hospices Civils de Lyon - Hôpital Edouard Herriot Chirurgie Digestive et Bariatrique 5 Place d'Arsonval - 69437 Lyon Cedex 03 - FRANCE

    Lyon, 69437

    Maud ROBERT, Professor, +33 4 72 11 62 63, maud.robert@chu-lyon.fr

    Maud ROBERT, Professor

    Recruiting

  • Service de Chirurgie Digestive, Hôpital Européen de Marseille, 6 rue Désirée Clary, 13003 MARSEILLE

    Marseille, 13003

    Lysa MACRON, MD

    Lysa MACRON, MD

    Recruiting

  • Département de chirurgie digestive et bariatrique CHU de Nantes - Site Hôtel-Dieu - HME 1 Place Alexis Ricordeau 44000 NANTES

    Nantes, 44000

    Claire BLANCHARD, MD PhD, +33 2 40 08 33 33, claire.blanchard@chu-nantes.fr

    Claire BLANCHARD, MD PhD

    Recruiting

  • Service de Chirurgie Digestive et Transplantation Hépatique, Hôpital de l'Archet 2, CHU de Nice

    Nice, 06202

    Imed BEN AMOR, MD

    Imed BEN AMOR, MD

    Not yet recruiting

  • Département de Chirurgie digestive Hôpital de la Source CHU d'ORLEANS 14 Avenue de l'hôpital 45100 ORLEANS LA SOURCE

    Orléans, 45100

    Adel ABOU-MRAD FRICQUEGNON, MD PhD, +33 2 38 22 95 10, adel.abou-mrad@chr-orleans.fr

    Adel ABOU-MRAD FRICQUEGNON, MD, PHD

    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, 75013

    Adriana TORCIVIA, MD PhD, +33 1 42 17 56 44, adriana.torcivia@aphp.fr

    Adriana TORCIVIA, MD PhD

    Recruiting

  • Département de chirurgie digestive, oncologique et bariatrique AP-HP - Hôpital Européen Georges Pompidou 20 rue Leblanc 75015 PARIS

    Paris, 75015

    Lionel REBIBO, MD PhD, +33 1 56 09 58 68, lionel.rebibo@aphp.fr

    Lionel REBIBO, MD PhD

    Recruiting

  • Département de chirurgie digestive, œsogastrique et bariatrique AP-HP - Hôpital Bichat - Claude-Bernard 46 Rue Henri Huchard 75018 PARIS

    Paris, 75018

    Tigran POGHOSYAN, MD PhD, +33 1 40 25 82 39, tigran.poghosyan@aphp.fr

    Tigran POGHOSYAN, MD PhD

    Recruiting

  • Département de chirurgie viscérale CHU de Poitiers 2 Rue de la Miletrie - CS 90577 - 86000 POITIERS

    Poitiers, 86000

    Jean-Pierre FAURE, MD PhD, +33 5.49.44.39.14, jean-pierre.FAURE@chu-poitiers.fr

    Jean-Pierre FAURE, MD PhD

    Recruiting

  • Clinique Chirurgicale Mutualiste 3 rue le verrier - BP 209 42100 SAINT ETIENNE

    Saint-Etienne, 42100

    Pierre BLANC, MD PhD, +33 4 77 81 82 88, PBLANC@mutualite-loire.com

    Pierre BLANC, MD, PHD

    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

    Strasbourg, 67091

    Elisa REITANO, MD

    Elisa REITANO, MD

    Recruiting

  • Service de Chirurgie Digestive Hôpital Rangueil - CHU de Toulouse 1 avenue du Pr Jean Poulhès - TSA 50032 31059 TOULOUSE Cedex 9

    Toulouse, 31059

    Géraud TUYERAS, MD PhD, +33 5 61 32 34 20, tuyeras.g@chu-toulouse.fr

    Géraud TUYERAS, MD PhD

    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

    Vandœuvre-lès-Nancy, 54511

    Claire NOMINE-CRIQUI, MD PhD, +33 3 83 15 71 43, c.nomine-criqui@chru-nancy.fr

    Claire NOMINE-CRIQUI, MD PhD

    Recruiting

Other trials in France

About this study

Official title: 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.

Read more

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
Obesity
Being tested
Robot-assisted surgical strategy, Conventional laparoscopic surgical strategy, Visual analog scale, EQ-5D-5L questionnaire, Impact of Weight on Quality of Life (IWQOL) questionnaire
Keywords
Obesity, Bariatric surgery, Robot
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-assisted surgical strategyProcedure or surgery

    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 strategyProcedure or surgery

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

  • Visual analog scaleOther

    All patients will have pain evaluation with visual analog scale

  • EQ-5D-5L questionnaireOther

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

  • Impact of Weight on Quality of Life (IWQOL) questionnaireOther

    All patients will have Quality of life assessment with IWQOL questionnaire

Study groups in NCT06858761
Study groupRoleWhat they receive
Robot-assisted surgical strategyExperimentalPrimary 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.
Receives: Procedure: Robot-assisted surgical strategy; Other: Visual analog scale; Other: EQ-5D-5L questionnaire; Other: Impact of Weight on Quality of Life (IWQOL) questionnaire
Conventional laparoscopic surgical strategyActive comparatorPrimary 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.
Receives: Procedure: Conventional laparoscopic surgical strategy; Other: Visual analog scale; Other: EQ-5D-5L questionnaire; Other: Impact of Weight on Quality of Life (IWQOL) questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1 year after surgery

Secondary outcomes (20)

  1. 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.

    Measured: End of the surgery

  2. 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

    Measured: 1, 3 and 12 months after surgery

  3. 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

    Measured: 1 day, 2 days and 1 month after surgery

  4. Readmission rate

    Number of patients readmitted within 1 year after surgery.

    Measured: 1, 3 and 12 months after surgery

  5. Reintervention rate

    Number of patients for whom reintervention was necessary within 1 year after surgery.

    Measured: 1, 3 and 12 months after surgery

  6. 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

    Measured: Before surgery and at 1, 3, 6 and 12 months after surgery

  7. 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.

    Measured: Before surgery and at 1, 3, 6 and 12 months after surgery

  8. Duration of surgery

    Operative time expressed in minutes

    Measured: End of the surgery

  9. 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

    Measured: at hospital discharge, an average of 3 days +- 2 days

  10. 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.

    Measured: Within 12 months after surgery

  11. Cost of the initial hospital stay

    the cost of the initial surgical stay for each group will be calculated using the micro-costing method

    Measured: at hospital discharge, an average of 3 days +- 2 days

  12. 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)

    Measured: 12 months after surgery

  13. 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)

    Measured: 12 months after surgery

  14. 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)

    Measured: 12 months after surgery

  15. 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)

    Measured: 12 months after surgery

  16. ICER depending on preoperative risk

    Ratio expressed as additional cost per Quality Adjusted Life Year gained (cost/QALY)

    Measured: 12 months after surgery

  17. Perform a budgeT impact analysis

    Financial consequences of adopting robotic from the perspective of the French public health care system at 5 years

    Measured: 5-year modelling

  18. 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).

    Measured: 6 and 12 months after surgery

  19. Changes in treatment

    Changes in treatment with antidiabetic, antihypertensive, lipid-lowering and gastro-oesophageal reflux medications

    Measured: 6 and 12 months after surgery

  20. Presence of sleep apnoea syndrome

    Assessment of the presence of sleep apnoea syndrome 6 and 12 months after surgery.

    Measured: 6 and 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2025
  2. Study start25 Jul 2025
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective multicenter randomized, controlled in 2 parallel groups, single-blind, superiority trial comparing 2 modalities of bariatric surgery (first-line or revision): * Robotic surgical strategy * Conventional laparoscopic surgical strategy
Masking
Single blind
Who is masked
Participant
Enrolment
482 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06858761
Sponsor's protocol ID
69HCL24_0757
Acronym
ROBOBAR
Status last verified
Jul 2026
First submitted
20 Feb 2025
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Robot-assisted surgical strategy, Conventional laparoscopic surgical strategy and Visual analog scale in people with Obesity, run by Hospices Civils de Lyon at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maud ROBERT, MD, PHD (+33 4 72 11 62 63, maud.robert@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incremental cost-effectivEness ratio (ICER) (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06858761.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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