National Multicenter Cohort Study of Robot-Assisted Gastrectomy Versus Laparoscopy in Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Compare robotic gastrectomy with the conventional laparoscopic approach in terms of oncologic safety.
研究概览
简要总结
In recent years there has been a rapid incursion of robotic technology applied to almost all fields of surgery. In gastric cancer, whose mainstay of treatment is still surgical resection, gastrectomy with robotic lymphadenectomy is growing faster than the scientific evidence supporting its results.
The "National Multicenter Cohort Study of ROBOT-Assisted Gastrectomy Versus Laparoscopy in Gastric Cancer" (ROBOTAG study) is proposed as a prospective multicenter Spanish nationwide study, comparing robotic gastrectomy versus conventional laparoscopic gastrectomy for the treatment of gastric cancer. This study aims to provide evidence on the feasibility, safety and complications, possible technical advantages, short and long term surgical and oncological results, as well as aspects related to quality of life, which can support the increase in cost and the important technological effort that underlies robotic surgery with respect to conventional laparoscopic access.
The relevance of this project is doubled by directing the objectives, on the one hand, on a new and expensive technology that is reaching hospitals still surrounded by controversy about its real benefits; and on the other hand, by acting on a pathology for which most of the available studies come from Eastern countries, sometimes not very applicable to the Western context.
详细描述
RELEVANCE OF THE STUDY
The project presented here is a pioneering study in Spain, which aims to provide scientific evidence on robot-assisted gastrectomy in gastric cancer. The feasibility, oncologic outcomes, potential benefits, complications and limitations will be investigated. Few hospitals in the country have robotic technology and also perform this surgical procedure. The aim is to include as many centers as possible in this study, which will involve an important effort, but also the search for answers of great scientific value and repercussion in the applicability of this innovation in western environment. It is hoped to be able to provide, both at the management level of the Spanish Health System and extensively in other countries, a basis for decision making to audit and, if necessary, endorse the development and diffusion of this technology in hospitals, in order to offer patients the best surgical option in the treatment of gastric cancer.
OBJECTIVES
The main objective of this study is to compare Robot-Assisted Gastrectomy (RAG) with conventional Laparoscopic Gastrectomy (LG), from the point of view of clinical and oncological safety.
In addition, possible differences between patients undergoing each technique will be analyzed in other aspects, both intraoperatively and postoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Compare robotic gastrectomy with the conventional laparoscopic approach in terms of oncologic safety.
时间窗: Intraoperative
Nodal count (number of lymph nodes retrieved) and R0 resection margin.
Compare robotic gastrectomy with the conventional laparoscopic approach in terms of clinical safety.
时间窗: Intraoperative and Postoperative (up to 90 days postoperative)
Intraoperative blood loss and perioperative complications (types of complications, Clavien Dindo classification, Comprehensive Complication Index (CCI®))
次要结局
- Compare robotic gastrectomy with the conventional laparoscopic approach in terms of intraoperative outcomes.(Intraoperative)
- Compare robotic gastrectomy with the conventional laparoscopic approach in terms of recovery and postoperative physical status.(Postoperative, up to 1 year after surgery)
- Compare robotic gastrectomy with the conventional laparoscopic approach in terms of oncological outcomes.(Assessment at 1, 3, 5 years from surgery)
- Compare robotic gastrectomy with the conventional laparoscopic approach in terms of cost-utility outcomes.(Assessment at 1 year from surgery)
研究者
MARÍA ASUNCIÓN ACOSTA MÉRIDA
Principal Investigator
Dr. Negrin University Hospital