National Multicenter Cohort Study of Robot-Assisted Gastrectomy Versus Laparoscopy in Gastric Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Robot-Assisted Gastrectomy: Gastrectomy performed with a robotic system.

Laparoscopic Gastrectomy: Gastrectomy performed with conventional laparoscopic approach.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Compare robotic gastrectomy with the conventional laparoscopic approach in terms of clinical safety. — Intraoperative and Postoperative (up to 90 days postoperative)
  Intraoperative blood loss and perioperative complications (types of complications, Clavien Dindo classification, Comprehensive Complication Index (CCI®))
• Compare robotic gastrectomy with the conventional laparoscopic approach in terms of oncologic safety. — Intraoperative
  Nodal count (number of lymph nodes retrieved) and R0 resection margin.

Trial sites (1)

More Hospital Universitario de Gran Canaria Doctor Negrín trials in Spain

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