Health-economic Assessment of Robot-assisted Bariatric Surgery

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

Interventions

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.

PROCEDURE

Conventional laparoscopic surgical strategy

Primary 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

Sponsors & Collaborators

• Hospices Civils de Lyon

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-25

Primary Completion

2028-07-31

Completion

2028-07-31

Countries

• France

Study Locations