Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy

Trial Title: Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy

NCT ID: NCT06362070

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

Conditions: Official terms:
Neoplasms
Adenocarcinoma
Stomach Neoplasms
Gastrointestinal Neoplasms

Conditions: Keywords:
Robotic-assisted surgery
Multiple surgical platforms
Postoperative complications
Operative outcomes
Gastrectomy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: DaVinci® Surgical System
Description: Assisted-robotic radical Gastrectomy
Arm group label: DaVinci® Surgical System

Intervention type: Device
Intervention name: Hugo™ RAS System
Description: Assisted-robotic radical Gastrectomy
Arm group label: Hugo™ RAS System

Intervention type: Device
Intervention name: Versius® Robotic Surgery System
Description: Assisted-robotic radical Gastrectomy
Arm group label: Versius® Robotic Surgery System

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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: General and Upper GI Unit

Address:
City: Verona
Zip: 37126
Country: Italy

Status: Recruiting

Contact:
Last name: Simone SG Giacopuzzi, MD, Prof

Phone: +39 0458127510
Email: simone.giacopuzzi@univr.it

Investigator:
Last name: Simone Giacopuzzi, MD, Prof
Email: Principal Investigator

Investigator:
Last name: Maria Bencivenga, MD, Prof
Email: Sub-Investigator

Start date: January 31, 2024

Completion date: July 31, 2025

Lead sponsor:
Agency: Azienda Ospedaliera Universitaria Integrata Verona
Agency class: Other

Source: Azienda Ospedaliera Universitaria Integrata Verona

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06362070