RecruitingNot ApplicableNCT06362070

Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy

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


Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Enrollment

75 participants

Start Date

Jan 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

  • Age \> 18 and \< 80 years
  • Informed consent provided
  • Primary stomach tumor
  • Total or subtotal gastrectomy
  • Tumour stage: T1-4a, any N, M0
  • ASA I-III
  • No BMI limits
  • Upfront surgery or after neoadjuvant chemotherapy

Exclusion Criteria7

  • Extension to esophagectomy
  • Tumor of the esophago-gastric junction (Siwert I-III)
  • Emergency surgery
  • Metastatic patients (stage IV)
  • Patients undergoing preoperative radiotherapy
  • Previous major supramesocolic surgery (excluding cholecystectomy)
  • Other coexisting malignant neoplasms

Interventions

DEVICEDaVinci® Surgical System

Assisted-robotic radical Gastrectomy

DEVICEHugo™ RAS System

Assisted-robotic radical Gastrectomy

DEVICEVersius® Robotic Surgery System

Assisted-robotic radical Gastrectomy


Locations(1)

General and Upper GI Unit

Verona, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06362070


Related Trials