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Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy

RECRUITINGN/ASponsored by Azienda Ospedaliera Universitaria Integrata Verona
Actively Recruiting
PhaseN/A
SponsorAzienda Ospedaliera Universitaria Integrata Verona
Started2024-01-31
Est. completion2024-03-30
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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

Conditions7

CancerGastric CancerGastric Diffuse AdenocarcinomaGastric NeoplasmGastrointestinal CancerNeoplasmsStomach Adenocarcinoma

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