Health-economic Assessment of Robot-assisted Bariatric Surgery

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура Conventional laparoscopic surgical strategy
  Primary or revision bariatric surgery (for complications or side effects of a previous surgery), using a conventional laparoscopic approach
• Другое Visual analog scale
  All patients will have pain evaluation with visual analog scale
• Другое EQ-5D-5L questionnaire
  All patients will have quality of life assessment with EQ-5D-5L questionnaire
• Другое Impact of Weight on Quality of Life (IWQOL) questionnaire
  All patients will have Quality of life assessment with IWQOL questionnaire

Первичные конечные точки

• Incremental cost-effectivEness ratio (ICER) [Срок оценки: 1 year after surgery]

Вторичные конечные точки (12)

• Number, type and severity of intraoperative complications [Срок оценки: End of the surgery]
• Number, type and severity of postoperative complications [Срок оценки: 1, 3 and 12 months after surgery]
• Pain assessment [Срок оценки: 1 day, 2 days and 1 month after surgery]
• Readmission rate [Срок оценки: 1, 3 and 12 months after surgery]
• Reintervention rate [Срок оценки: 1, 3 and 12 months after surgery]
• Quality of life assessment with EQ-5D-5L questionnaire [Срок оценки: Before surgery and at 1, 3, 6 and 12 months after surgery]
• Quality of life assessment with IWQOL questionnaire [Срок оценки: Before surgery and at 1, 3, 6 and 12 months after surgery]
• Duration of surgery [Срок оценки: End of the surgery]
• Length of hospital stay [Срок оценки: at hospital discharge, an average of 3 days +- 2 days]
• Readmission rate in High Dependency unit and/or intensive care unit [Срок оценки: Within 12 months after surgery]
• Cost of the initial hospital stay [Срок оценки: 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 [Срок оценки: 12 months after surgery]

Критерии участия

Критерии включения

• 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
• 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,

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 18 центров

• Département de chirurgie digestive et endocrinienne Groupe Hospitalier Pellegrin Place Amé — Bordeaux
• Département de chirurgie digestive CHRU Dijon - Hôpital Le Bocage Bd du Maréchal de Lattre — Dijon
• Digestive Surgery Department CHU Grenoble BP217 - 38043 GRENOBLE Cedex 09 — Grenoble
• Service de Chirurgie Générale et Digestive Grand Hopital de l'Est Francilien Site de Marne — Jossigny
• Service de Chirurgie Générale et Endocrinienne CHU de Lille - Hôpital Claude Huriez 1 rue — Lille
• Hospices Civils de Lyon - Hôpital Edouard Herriot Chirurgie Digestive et Bariatrique 5 Pla — Lyon
• Service de Chirurgie Digestive, Hôpital Européen de Marseille, 6 rue Désirée Clary, 13003 — Marseille
• Département de chirurgie digestive et bariatrique CHU de Nantes - Site Hôtel-Dieu - HME 1 — Nantes
• … и ещё 10 центров

Идентификаторы

NCT: NCT06858761 · 69HCL24_0757

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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