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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:
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:
Participants will be enrolled, after obtaining informed consent, in one of the following cohorts:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DaVinci® Surgical System | Active Comparator | 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) |
|
| Hugo™ RAS System | Experimental | 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) |
|
| Versius® Robotic Surgery System | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DaVinci® Surgical System | Device | Assisted-robotic radical Gastrectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion 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 | 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. | 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). | Intraoperative |
| Analysis of video of surgical procedures (Phase 2) | Evaluation of analysis of video of surgical procedure, as deviations from the standard. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Blood Loss | Volume of blood loss (ml) | Intraoperative |
| Overall duration of the surgery | Minutes | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simone SG Giacopuzzi, MD, Prof | Contact | +39 0458127510 | simone.giacopuzzi@univr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General and Upper GI Unit | Recruiting | Verona | 37126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35047788 | Result | Haig F, Medeiros ACB, Chitty K, Slack M. Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery. BMJ Surg Interv Health Technol. 2020 May 22;2(1):e000028. doi: 10.1136/bmjsit-2019-000028. eCollection 2020. | |
| 29442240 | Result | Peters BS, Armijo PR, Krause C, Choudhury SA, Oleynikov D. Review of emerging surgical robotic technology. Surg Endosc. 2018 Apr;32(4):1636-1655. doi: 10.1007/s00464-018-6079-2. Epub 2018 Feb 13. |
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| Hugo™ RAS System |
| Device |
Assisted-robotic radical Gastrectomy |
|
| Versius® Robotic Surgery System | Device | Assisted-robotic radical Gastrectomy |
|
| Anesthesia, Lymphadenectomy, Gastrectomy (10 different surgical steps) | Minutes | 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 | 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. | 1-7 days postoperative |
| Postoperative hospitalization | Days of recovery until the date of release | 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" | 1-5 days postoperative |
| Re-admission rate to hospitalization | Number of patients readmitted to the hospital for postoperative complications | Up to 90 days postoperative |
| Damage due to positioning | Number of damage due to positioning on the operating bed, during the surgical procedure | Intraoperative |
| Positive Surgical Margin | Positive margin (distal or proximal) at histological examination | Up to 2 weeks postoperative (during histological analysis) |
| Lymph nodes resection | Number of lymph nodes removed | 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) | 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 | From the room setting, through surgical procedure until postoperative room restoration for each of expected surgeries |
| Possible malfunction of the platform | Note | 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. | Intraoperative |
| Procedure-related costs | Estimate | From surgical procedure up to 90 days after surgery |
| 33340239 | Result | Solaini L, D'Ignazio A, Marrelli D, Marano L, Avanzolini A, Morgagni P, Roviello F, Ercolani G. The effect of learning curve on perioperative outcomes of robotic gastrectomy in two western high-volume centers. Int J Med Robot. 2021 Apr;17(2):e2212. doi: 10.1002/rcs.2212. Epub 2021 Jan 8. |
| 35472517 | Result | Li Z, Qian F, Zhao Y, Chen J, Zhang F, Li Z, Wang X, Li P, Liu J, Wen Y, Feng Q, Shi Y, Yu P. A comparative study on perioperative outcomes between robotic versus laparoscopic D2 total gastrectomy. Int J Surg. 2022 Jun;102:106636. doi: 10.1016/j.ijsu.2022.106636. Epub 2022 Apr 26. |
| 37010634 | Result | Shibasaki S, Suda K, Hisamori S, Obama K, Terashima M, Uyama I. Robotic gastrectomy for gastric cancer: systematic review and future directions. Gastric Cancer. 2023 May;26(3):325-338. doi: 10.1007/s10120-023-01389-y. Epub 2023 Apr 3. |
| 37623483 | Result | Prata F, Ragusa A, Tempesta C, Iannuzzi A, Tedesco F, Cacciatore L, Raso G, Civitella A, Tuzzolo P, Calle P, Pira M, Pino M, Ricci M, Fantozzi M, Prata SM, Anceschi U, Simone G, Scarpa RM, Papalia R. State of the Art in Robotic Surgery with Hugo RAS System: Feasibility, Safety and Clinical Applications. J Pers Med. 2023 Aug 6;13(8):1233. doi: 10.3390/jpm13081233. |
| 29846827 | Result | Baiocchi GL, Giacopuzzi S, Marrelli D, Reim D, Piessen G, Matos da Costa P, Reynolds JV, Meyer HJ, Morgagni P, Gockel I, Lara Santos L, Jensen LS, Murphy T, Preston SR, Ter-Ovanesov M, Fumagalli Romario U, Degiuli M, Kielan W, Monig S, Kolodziejczyk P, Polkowski W, Hardwick R, Pera M, Johansson J, Schneider PM, de Steur WO, Gisbertz SS, Hartgrink H, van Sandick JW, Portolani N, Holscher AH, Botticini M, Roviello F, Mariette C, Allum W, De Manzoni G. International consensus on a complications list after gastrectomy for cancer. Gastric Cancer. 2019 Jan;22(1):172-189. doi: 10.1007/s10120-018-0839-5. Epub 2018 May 30. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D009369 | Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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