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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
General and Upper GI Unit
RECRUITING
Verona
Contact Information
Primary
Simone SG Giacopuzzi, MD, Prof
simone.giacopuzzi@univr.it
+39 0458127510
Time Frame
Start Date: 2024-01-31
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 75
Treatments
Active_comparator: DaVinci® Surgical System
Robot-assisted total or subtotal Gastrectomy is carried out through daVinci platform.~(10 patients enrolled for phase 1 of the study and 15 patients for phase 2)
Experimental: Hugo™ RAS System
Robot-assisted total or subtotal Gastrectomy is carried out through Hugo platform.~(10 patients enrolled for phase 1 of the study and 15 patients for phase 2)
Experimental: Versius® Robotic Surgery System
Robot-assisted total or subtotal Gastrectomy is carried out through Versius platform.~(10 patients enrolled for phase 1 of the study and 15 patients for phase 2)
Related Therapeutic Areas
Sponsors
Leads: Azienda Ospedaliera Universitaria Integrata Verona

This content was sourced from clinicaltrials.gov