Health-economic Assessment of Robot-assisted Bariatric Surgery

NCT06858761 | Recruiting

• 1 other identifier: 69HCL24_0757
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 16

Brief 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. 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

Obesity

Keywords

Obesity; Bariatric surgery; Robot

Outcome Measures

Primary Outcomes (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)

  1 year after surgery

Secondary Outcomes (17)

• Number, type and severity of intraoperative complications

  End of the surgery

• Number, type and severity of postoperative complications

  1, 3 and 12 months after surgery

• Pain assessment

  1 day, 2 days and 1 month after surgery

• Readmission rate

  1, 3 and 12 months after surgery

• Reintervention rate

  1, 3 and 12 months after surgery

Study Arms (2)

Robot-assisted surgical strategy

EXPERIMENTAL

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; Other: Visual analog scale; Other: EQ-5D-5L questionnaire; Other: Impact of Weight on Quality of Life (IWQOL) questionnaire

Conventional laparoscopic surgical strategy

ACTIVE COMPARATOR

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.

Procedure: Conventional laparoscopic surgical strategy; Other: Visual analog scale; Other: EQ-5D-5L questionnaire; Other: Impact of Weight on Quality of Life (IWQOL) questionnaire

Interventions

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.

Robot-assisted surgical strategy

Conventional laparoscopic surgical strategy PROCEDURE

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

Conventional laparoscopic surgical strategy

Visual analog scale OTHER

All patients will have pain evaluation with visual analog scale

Conventional laparoscopic surgical strategy; Robot-assisted surgical strategy

EQ-5D-5L questionnaire OTHER

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

Conventional laparoscopic surgical strategy; Robot-assisted surgical strategy

Impact of Weight on Quality of Life (IWQOL) questionnaire OTHER

All patients will have Quality of life assessment with IWQOL questionnaire

Conventional laparoscopic surgical strategy; Robot-assisted surgical strategy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• kg/m² OR
• 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
• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (16)

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

Bordeaux, 33076, France

RECRUITING

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

Dijon, 21000, France

RECRUITING

Digestive Surgery Department CHU Grenoble BP217 - 38043 GRENOBLE Cedex 09

Grenoble, 38043, 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, 77600, France

RECRUITING

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

Lille, 59000, France

RECRUITING

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

Lyon, 69437, France

RECRUITING

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

Nantes, 44000, France

RECRUITING

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

Orléans, 45100, 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, 75013, France

RECRUITING

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

Paris, 75015, France

RECRUITING

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

Paris, 75018, France

RECRUITING

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

Poitiers, 86000, France

RECRUITING

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

Saint-Etienne, 42100, France

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, France

RECRUITING

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

Toulouse, 31059, France

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, France

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind study: patient will not be informed of the approach (laparoscopic or robotic) which will be used for their intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 5, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

FR (16)