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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- 24h postoperative pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
24h postoperative pain
时间窗: 24h
Pain assessment 24h post surgery (visual analog scale)
次要结局
- Evaluation of post-operative pain(24h, 8 days, 1, 3, 6 and 12 months)
- Evaluation of quality of life (BAROS and GIQLI)(At 1, 3, 6 and 12 months)
- Evaluation of appetite level(At 8 days, 1, 3, 6 and 12 months)
- Percentage of excess weight loss(At 8 days, 1, 3, 6 and 12 months)
- Conversion rate to conventional laparoscopy(During the procedure (Day 0))
- Nature of per-operative complications(During the procedure (Day 0))
- Nature of post-operative complications(Following the procedure (Day 0) up to 12 months)
- Evaluation of operative times(During the procedure (Day 0))
- Evaluation of direct costs(During the procedure (day 0) and up to 12 months)
- Evaluation of indirect costs(Up to 12 months)