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

Gastric Cancer Gastrointestinal Cancer Neoplasms Gastric Neoplasm Gastric Diffuse Adenocarcinoma Stomach Adenocarcinoma

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

Plain Language Summary

Simplified for easier understanding

This study is comparing the outcomes of different robotic surgery platforms used to perform gastrectomy (stomach removal) for stomach cancer, to see which robotic system produces the best results for patients in terms of safety, recovery, and surgical precision. **You may be eligible if...** - You are 18–79 years old - You have a primary stomach tumor (gastric cancer) - You are scheduled for total or subtotal gastrectomy (full or partial stomach removal) - Your cancer stage is T1–4a (any lymph node involvement), without distant metastases (M0) - You are in acceptable surgical health (ASA Class I–III) - You may have received neoadjuvant chemotherapy before surgery **You may NOT be eligible if...** - Your surgery also requires removal of part of the esophagus - Your tumor is at the esophago-gastric junction (Siewert types I–III) - You require emergency surgery - You have cancer that has spread to distant organs (Stage IV) - You are undergoing preoperative radiation therapy - You have had previous major abdominal surgery above the transverse colon (excluding gallbladder removal) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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