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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Assisted-robotic radical Gastrectomy
Assisted-robotic radical Gastrectomy
Assisted-robotic radical Gastrectomy
General and Upper GI Unit
Verona, Italy
RECRUITINGConversion rate to open or laparoscopic approach (Phase 1)
Number of procedures in which it is necessary to convert to open or laparoscopic approach, due to surgical and/or oncological needs
Time frame: Intraoperative
Number of participants with major intraoperative complications (Phase 1)
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.
Time frame: Intraoperative
Evaluation of surgical times of the standardized procedures (Phase 2)
Analysis of surgical times (as minutes of the different surgical steps of the standardized procedure).
Time frame: Intraoperative
Analysis of video of surgical procedures (Phase 2)
Evaluation of analysis of video of surgical procedure, as deviations from the standard.
Time frame: Intraoperative
Estimated Blood Loss
Volume of blood loss (ml)
Time frame: Intraoperative
Overall duration of the surgery
Minutes
Time frame: Intraoperative
Anesthesia, Lymphadenectomy, Gastrectomy (10 different surgical steps)
Minutes
Time frame: Entrance of patient into operating room until completion of surgery
Number of participants with major postoperative complications
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
Time frame: Until 90 days post surgery
Compliance rate to ERAS protocol
Adherence to Enhanced recovery after surgery for gastric cancer (ERAS-GC) protocol, which involves a rapid mobilisation and refeeding of patiens.
Time frame: 1-7 days postoperative
Postoperative hospitalization
Days of recovery until the date of release
Time frame: From the surgery day up to 20 days postoperative
Postoperative pain
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"
Time frame: 1-5 days postoperative
Re-admission rate to hospitalization
Number of patients readmitted to the hospital for postoperative complications
Time frame: Up to 90 days postoperative
Damage due to positioning
Number of damage due to positioning on the operating bed, during the surgical procedure
Time frame: Intraoperative
Positive Surgical Margin
Positive margin (distal or proximal) at histological examination
Time frame: Up to 2 weeks postoperative (during histological analysis)
Lymph nodes resection
Number of lymph nodes removed
Time frame: Up to 2 weeks postoperative (during histological analysis)
Quality of Life Evaluation
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)
Time frame: Postoperaive (follow up at 1 month)
Time taken for platform-related technical steps
Set up of operating table, Electric connections, Draping, Undraping, Docking, Undocking, Cleaning: time in minutes
Time frame: From the room setting, through surgical procedure until postoperative room restoration for each of expected surgeries
Possible malfunction of the platform
Note
Time frame: Intraoperative
Non-Technical Skills Assessment (NTS) demonstrated by members of the surgical team during the intraoperative phase.
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.
Time frame: Intraoperative
Procedure-related costs
Estimate
Time frame: From surgical procedure up to 90 days after surgery
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