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.
Azienda Ospedaliera Universitaria Integrata Verona
75 participants
Jan 31, 2024
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
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
Assisted-robotic radical Gastrectomy
Assisted-robotic radical Gastrectomy
Assisted-robotic radical Gastrectomy
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06362070