Clinical trial NCT06858761: Health-economic Assessment of Robot-assisted Bariatric Surgery
Official title: Health Economic Impact of Robot-assisted Bariatric Surgery vs Conventional Laparoscopy: Prospective Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Obesity
Bariatric surgery
Robot
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Incremental cost-effectivEness ratio (ICER)
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Number, type and severity of intraoperative complications
timeFrame: End of the surgery
measure: Number, type and severity of postoperative complications
timeFrame: 1, 3 and 12 months after surgery
measure: Pain assessment
timeFrame: 1 day, 2 days and 1 month after surgery
measure: Readmission rate
timeFrame: 1, 3 and 12 months after surgery
measure: Reintervention rate
timeFrame: 1, 3 and 12 months after surgery
measure: Quality of life assessment with EQ-5D-5L questionnaire
timeFrame: Before surgery and at 1, 3, 6 and 12 months after surgery
measure: Quality of life assessment with IWQOL questionnaire
timeFrame: Before surgery and at 1, 3, 6 and 12 months after surgery
measure: Duration of surgery
timeFrame: End of the surgery
measure: Length of hospital stay
timeFrame: at hospital discharge, an average of 3 days +- 2 days
measure: Readmission rate in High Dependency unit and/or intensive care unit
timeFrame: Within 12 months after surgery
measure: Cost of the initial hospital stay
timeFrame: at hospital discharge, an average of 3 days +- 2 days
measure: ICER in subgroup of patients with preoperative BMI < 50 versus patients with preoperative BMI > 50 kg/m2
timeFrame: 12 months after surgery
measure: ICER in subgroup of patients age > 60 years old versus patients age < 60 years
timeFrame: 12 months after surgery
measure: ICER in subgroup of patients with primary surgery versus patients with revisional surgery
timeFrame: 12 months after surgery
measure: ICER in subgroup of patients with restrictive surgery versus patients with malabsorptive surgery
timeFrame: 12 months after surgery
measure: ICER depending on preoperative risk
timeFrame: 12 months after surgery
measure: Perform a budgeT impact analysis
timeFrame: 5-year modelling
Other outcomes:
Locations:
city: Bordeaux (france)
country: France
facility: Département de chirurgie digestive et endocrinienne Groupe Hospitalier Pellegrin Place Amélie Raba Léon 33076 BORDEAUX
city: Dijon (france)
country: France
facility: Département de chirurgie digestive CHRU Dijon - Hôpital Le Bocage Bd du Maréchal de Lattre de Tassigny 21000 DIJON
city: Grenoble (france)
country: France
facility: Digestive Surgery Department CHU Grenoble BP217 - 38043 GRENOBLE Cedex 09
city: Jossigny (france)
country: France
facility: 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
city: Lille ( France)
country: France
facility: Service de Chirurgie Générale et Endocrinienne CHU de Lille - Hôpital Claude Huriez 1 rue Michel Polonovski 59000 LILLE
city: Lyon (france)
country: France
facility: Hospices Civils de Lyon - Hôpital Edouard Herriot Chirurgie Digestive et Bariatrique 5 Place d'Arsonval - 69437 Lyon Cedex 03 - FRANCE
city: Nantes (france)
country: France
facility: Département de chirurgie digestive et bariatrique CHU de Nantes - Site Hôtel-Dieu - HME 1 Place Alexis Ricordeau 44000 NANTES
city: Orleans (france)
country: France
facility: Département de Chirurgie digestive Hôpital de la Source CHU d'ORLEANS 14 Avenue de l'hôpital 45100 ORLEANS LA SOURCE
city: Paris (france)
country: France
facility: 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
city: Paris (france)
country: France
facility: Département de chirurgie digestive, oncologique et bariatrique AP-HP - Hôpital Européen Georges Pompidou 20 rue Leblanc 75015 PARIS
city: Paris (france)
country: France
facility: Département de chirurgie digestive, œsogastrique et bariatrique AP-HP - Hôpital Bichat - Claude-Bernard 46 Rue Henri Huchard 75018 PARIS
city: Poitiers (france)
country: France
facility: Département de chirurgie viscérale CHU de Poitiers 2 Rue de la Miletrie - CS 90577 - 86000 POITIERS
city: SAINT ETIENNE (France)
country: France
facility: Clinique Chirurgicale Mutualiste 3 rue le verrier - BP 209 42100 SAINT ETIENNE
city: Strasbourg (france)
country: France
facility: 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
city: Toulouse (france)
country: France
facility: Service de Chirurgie Digestive Hôpital Rangueil - CHU de Toulouse 1 avenue du Pr Jean Poulhès - TSA 50032 31059 TOULOUSE Cedex 9
city: Vandoeuvre Les Nancy (france)
country: France
facility: 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
Study officials:
References: