Gastric Cancer, Gastric Diffuse Adenocarcinoma, Gastric Neoplasm, Gastrointestinal Cancer, Neoplasms, Stomach Adenocarcinoma
Conditions
Keywords
Robotic-assisted surgery, Multiple surgical platforms, Postoperative complications, Operative outcomes, Gastrectomy
Brief 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.
Interventions
DEVICEVersius® Robotic Surgery System
Assisted-robotic radical Gastrectomy
DEVICEDaVinci® Surgical System
Assisted-robotic radical Gastrectomy
DEVICEHugo™ RAS System
Assisted-robotic radical Gastrectomy
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion rate to open or laparoscopic approach (Phase 1) | Intraoperative | Number of procedures in which it is necessary to convert to open or laparoscopic approach, due to surgical and/or oncological needs |
| Number of participants with major intraoperative complications (Phase 1) | Intraoperative | 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. |
| Evaluation of surgical times of the standardized procedures (Phase 2) | Intraoperative | Analysis of surgical times (as minutes of the different surgical steps of the standardized procedure). |
| Analysis of video of surgical procedures (Phase 2) | Intraoperative | Evaluation of analysis of video of surgical procedure, as deviations from the standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance rate to ERAS protocol | 1-7 days postoperative | Adherence to Enhanced recovery after surgery for gastric cancer (ERAS-GC) protocol, which involves a rapid mobilisation and refeeding of patiens. |
| Postoperative hospitalization | From the surgery day up to 20 days postoperative | Days of recovery until the date of release |
| Postoperative pain | 1-5 days postoperative | 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 |
| Re-admission rate to hospitalization | Up to 90 days postoperative | Number of patients readmitted to the hospital for postoperative complications |
| Damage due to positioning | Intraoperative | Number of damage due to positioning on the operating bed, during the surgical procedure |
| Positive Surgical Margin | Up to 2 weeks postoperative (during histological analysis) | Positive margin (distal or proximal) at histological examination |
| Estimated Blood Loss | Intraoperative | Volume of blood loss (ml) |
| Quality of Life Evaluation | Postoperaive (follow up at 1 month) | 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 taken for platform-related technical steps | From the room setting, through surgical procedure until postoperative room restoration for each of expected surgeries | Set up of operating table, Electric connections, Draping, Undraping, Docking, Undocking, Cleaning: time in minutes |
| Possible malfunction of the platform | Intraoperative | Note |
| Non-Technical Skills Assessment (NTS) demonstrated by members of the surgical team during the intraoperative phase. | Intraoperative | 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. |
| Procedure-related costs | From surgical procedure up to 90 days after surgery | Estimate |
| Lymph nodes resection | Up to 2 weeks postoperative (during histological analysis) | Number of lymph nodes removed |
| Overall duration of the surgery | Intraoperative | Minutes |
| Anesthesia, Lymphadenectomy, Gastrectomy (10 different surgical steps) | Entrance of patient into operating room until completion of surgery | Minutes |
| Number of participants with major postoperative complications | Until 90 days post surgery | 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 |
Countries
Italy
Contacts
Primary ContactSimone SG Giacopuzzi, MD, Prof
Outcome results
None listed