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RECRUITING
NCT06362070
NA

Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy

Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

View on ClinicalTrials.gov

Summary

The object of this exploratory clinical trial is to evaluate intra and post-operative complications in a population that underwent Robotic Gastrectomy, with multiple platforms: * DaVinci; * Hugo; * Versius. This study is divided into two phases: in the first phase, gastrectomy will be performed using both the new platforms (Hugo and Versius) and the standard platform (Da Vinci), to evaluate the feasibility of the surgical procedure. In the second phase, the three platforms will be compared to evaluate any differences in the learning curve for an upper-GI surgeon, expert in laparoscopic surgery but not with robotic one. The questions it aims to answer are: * Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three different platforms observable? * Are there any differences between the three platforms related to the learning curve for surgeons? Participants will be enrolled, after obtaining informed consent, in one of the following cohorts: 1. surgery with the daVinci platform; 2. surgery with the Hugo platform; 3. surgery with the Versius platform.

Official title: Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy (COMPAR-G) in Gastric Cancer Patient.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2024-01-31

Completion Date

2025-07-31

Last Updated

2024-04-12

Healthy Volunteers

No

Interventions

DEVICE

DaVinci® Surgical System

Assisted-robotic radical Gastrectomy

DEVICE

Hugo™ RAS System

Assisted-robotic radical Gastrectomy

DEVICE

Versius® Robotic Surgery System

Assisted-robotic radical Gastrectomy

Locations (1)

General and Upper GI Unit

Verona, Italy