Clinical and Health Economic Impact of Robot-assisted Surgery vs Conventional Laparoscopy : the Case of Gastric Bypass

Study Overview
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Brief Summary
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The purpose of this study is to gather clinical and economic evidence on the use of robotics for bariatric surgery (gastric bypass). This monocentric, randomized, single blind, controlled study will evaluate post-operative pain, quality of life and appetite, post-operative complication incidence. It will also provide information on direct and indirect costs of surgery.

Detailed Description
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Robot-assisted Surgery Versus Conventional Laparoscopy in Bariatric Surgery (Gastric Bypass): a prospective, single-blind, randomized, non-inferiority, and controlled study The main evaluation criterion is 24h post-operative pain assessed using visual analog scale (VAS). Secondary criteria included for clinical assessment: post 24h pain, excess weight loss, quality of life, appetite, complications, conversion rate; and for health-economics assessment : duration of surgical steps, length of stay, return to normal activity and their conversion to cost, consumables, estimation of indirect costs and benefits (e.g., robotics perception, publication). In this study, main inclusion criteria include major obesity (IMC ≥ 35) with co-morbidities or morbid obesity (IMC ≥ 40), scheduled gastric bypass surgery Main contraindications are previous bariatric surgery and previous major abdominal surgeries To test robotic-assisted surgery non-inferiority on VAS pain score 24h post-surgery, a total of 128 patients (64 per arm) is to be included (alpha 2,5%; power 90%; drop-out rate: 5%). The study will include 12 months of follow-up post-surgery for each patient. The total study duration is 2 years and 3 months.

Official Title
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Prospective, Single-blind, Randomized, Non-inferiority, and Controlled Study of Clinical and Health Economic Impact of Robot-assisted Surgery Versus Conventional Laparoscopy in Bariatric Surgery: the Case of Gastric Bypass

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Gastric bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient presenting with major obesity (BMI ≥ 35) with co-morbidities or morbid obesity (BMI ≥ 40)according to French HAS (Haute Autorité de Santé) and CNAMTS (Caisse nationale de l'assurance maladie des travailleurs salariés)criteria for whom gastric bypass is scheduled Male or female between 18 and 65 years old Patient registered with the French Social Security Patient having provided a written informed consent prior to enrolment Patient accepting to attend follow-up visits as required by study protocol Exclusion Criteria: Patient with a BMI ≥ 60 Patient with a contraindication for laparoscopic gastric bypass with or without robotic assistance Patient having had prior bariatric surgery Patient having had prior major abdominal surgery Patient in exclusion period of another clinical study Patient pregnant or breastfeeding Patient without sufficient knowledge of french language or unable to receive or understand study related information and answer to questionnaires Patient with no or limited legal capacity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted surgery<br>Robot-assisted (da Vinci surgical system) gastric bypass | Procedure: Gastric bypass<br>* Gastric bypass<br>|
| Active Comparator: Conventional laparoscopy<br>Laparoscopic gastric bypass | Procedure: Gastric bypass<br>* Gastric bypass<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24h postoperative pain | Pain assessment 24h post surgery (visual analog scale) | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of post-operative pain | Evaluation of post-operative pain (beyond 24h post-operative) using VAS | 24h, 8 days, 1, 3, 6 and 12 months | 
| Evaluation of quality of life (BAROS and GIQLI) | Evaluation of quality of life using BAROS and GIQLI questionaires | At 1, 3, 6 and 12 months | 
| Evaluation of appetite level | Evaluation of appetite level using VAS | At 8 days, 1, 3, 6 and 12 months | 
| Percentage of excess weight loss | Measure of excess weight loss - % from baseline | At 8 days, 1, 3, 6 and 12 months | 
| Conversion rate to conventional laparoscopy | Conversion rate to conventional laparoscopy (only applicable to robot-assisted surgery arm) | During the procedure (Day 0) | 
| Nature of per-operative complications | Nature of per-operative complications | During the procedure (Day 0) | 
| Nature of post-operative complications | Nature of post-operative complications | Following the procedure (Day 0) up to 12 months | 
| Evaluation of operative times | Evaluation of key steps of gastric bypass surgery, OR occupation time | During the procedure (Day 0) | 
| Evaluation of direct costs | Direct costs include material used, OR occupation time, length of stay, return to normal activity | During the procedure (day 0) and up to 12 months | 
| Evaluation of indirect costs | Combination of number of patients having surgery, perception of robot-assisted surgery by both personnel and patients, publications, and communications | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric bypass, Robot-assisted surgery, Conventional laparoscopy, Pain assessment, Health economics outcomes