Neoplasms

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Digestive System Diseases

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Stomach Neoplasms

Gastrointestinal Neoplasms

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Neoplasms by Histologic Type

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

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)

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)

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)

DaVinci® Surgical System

Hugo™ RAS System

Versius® Robotic Surgery System

Simone SG Giacopuzzi, MD, Prof

Simone Giacopuzzi, MD, Prof

Maria Bencivenga, MD, Prof

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.

Gastrectomy for gastric cancer could be performed through open, laparoscopic and robotic approaches. In the last ten years, robotic surgery, performed with Da Vinci® Robotic System (Intuitive Surgical Inc., Sunnyvale, CA, USA) has been introduced and increasingly used globally also in the field of gastric surgery. Indeed, the technological implementation obtained with the use of robotic surgery should guarantee an easier approach to the different phases of gastric surgery, and in particular to the more complex steps relating to the reconstructive phase of the operation.

Recently, after Intuitive patent expiration, two new CE-marked robotic platforms are available in Europe for minimally invasive procedures:

* Versius® Robotic Surgery System, (Cambridge Medical Robotics (CMR) Ltd., Cambridge, UK);
* HugoTM RAS (Medtronic Dublin, Ireland; Minneapolis, MN, USA).

Both platforms are currently used for urological and gynecological procedures, but, no experiences are reported in Literature related to the field of oncological esophago-gastric surgery. In order to provide evidence regarding the new robotic platforms, the COMPAR-G study has been designed to directly compare the Da Vinci® (as standard), Versius® and HugoTM RAS robotic platforms during gastrectomy.

In this regard, this study was proposed, divided into two phases: a first phase for feasibility of surgical procedure with different platforms and the second one to evaluate the learning curve for surgeons.

This second phase will be carried out only in the event of an extension of the rental of the two new platforms for a further period of one year.

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.

Number of procedures in which it is necessary to convert to open or laparoscopic approach, due to surgical and/or oncological needs

Major complications are considered according to the GASTRODATA definition (Unintentional intraoperative damage to major vessels and/or organs requiring reconstruction or resection. Intraoperative bleeding requiring urgent treatment. Unforeseen medical conditions that interrupt or change the planned procedure) and according to Clavien-Dindo Classification (7 grades: I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication.

Analysis of surgical times (as minutes of the different surgical steps of the standardized procedure).

Evaluation of analysis of video of surgical procedure, as deviations from the standard.

Major complications are considered according to GASTRODATA definition (surgical and/or general) and according to Clavien-Dindo Classification (7 grades: I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication

Adherence to Enhanced recovery after surgery for gastric cancer (ERAS-GC) protocol, which involves a rapid mobilisation and refeeding of patiens.

Days of recovery until the date of release

Numerical Rating Scale (NRS) 0-10 scale for the self-reported rate of pain: zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Number of patients readmitted to the hospital for postoperative complications

Number of damage due to positioning on the operating bed, during the surgical procedure

Positive margin (distal or proximal) at histological examination

EORTC QLQ-C30 questionnaire (30-item instrument designed to measure quality of life in all cancer patients) and EORTC STO-22 questionnaire (for measuring the QOL of patient with gastric cancer)

Set up of operating table, Electric connections, Draping, Undraping, Docking, Undocking, Cleaning: time in minutes

Targeted observation with "I.C.A.R.S" checklist (Interpersonal and Cognitive

Assessment for Robotic Surgery) which includes following domains:

Checklist and equipment; Interpersonal skills and Cognitive skills.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy	NCT06362070	Gastric Cancer Gastrointestina... Neoplasms Gastric Diffuse... Gastric Neoplas... Stomach Adenoca...	DaVinci® Surgic... Hugo™ RAS Syste... Versius® Roboti...	18 Years - 80 Years	Azienda Ospedaliera Universitaria Integrata Verona
Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy	NCT06362070	Gastric Cancer Gastrointestina... Neoplasms Gastric Diffuse... Gastric Neoplas... Stomach Adenoca...	DaVinci® Surgic... Hugo™ RAS Syste... Versius® Roboti...	18 Years - 80 Years	Azienda Ospedaliera Universitaria Integrata Verona
Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy	NCT06362070	Gastric Cancer Gastrointestina... Neoplasms Gastric Diffuse... Gastric Neoplas... Stomach Adenoca...	DaVinci® Surgic... Hugo™ RAS Syste... Versius® Roboti...	18 Years - 80 Years	Azienda Ospedaliera Universitaria Integrata Verona

Spots Global Cancer Trial Database for gastric diffuse adenocarcinoma