Clinical trial NCT06362070: Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy
Official title: Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy (COMPAR-G) in Gastric Cancer Patient.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Gastrointestinal Cancer
Neoplasms
Gastric Diffuse Adenocarcinoma
Gastric Neoplasm
Stomach Adenocarcinoma
Keywords: Robotic-assisted surgery
Multiple surgical platforms
Postoperative complications
Operative outcomes
Gastrectomy
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Conversion rate to open or laparoscopic approach (Phase 1)
timeFrame: Intraoperative
measure: Number of participants with major intraoperative complications (Phase 1)
timeFrame: Intraoperative
measure: Evaluation of surgical times of the standardized procedures (Phase 2)
timeFrame: Intraoperative
measure: Analysis of video of surgical procedures (Phase 2)
timeFrame: Intraoperative
Secondary outcomes:
measure: Estimated Blood Loss
timeFrame: Intraoperative
measure: Overall duration of the surgery
timeFrame: Intraoperative
measure: Anesthesia, Lymphadenectomy, Gastrectomy (10 different surgical steps)
timeFrame: Entrance of patient into operating room until completion of surgery
measure: Number of participants with major postoperative complications
timeFrame: Until 90 days post surgery
measure: Compliance rate to ERAS protocol
timeFrame: 1-7 days postoperative
measure: Postoperative hospitalization
timeFrame: From the surgery day up to 20 days postoperative
measure: Postoperative pain
timeFrame: 1-5 days postoperative
measure: Re-admission rate to hospitalization
timeFrame: Up to 90 days postoperative
measure: Damage due to positioning
timeFrame: Intraoperative
measure: Positive Surgical Margin
timeFrame: Up to 2 weeks postoperative (during histological analysis)
measure: Lymph nodes resection
timeFrame: Up to 2 weeks postoperative (during histological analysis)
measure: Quality of Life Evaluation
timeFrame: Postoperaive (follow up at 1 month)
measure: Time taken for platform-related technical steps
timeFrame: From the room setting, through surgical procedure until postoperative room restoration for each of expected surgeries
measure: Possible malfunction of the platform
timeFrame: Intraoperative
measure: Non-Technical Skills Assessment (NTS) demonstrated by members of the surgical team during the intraoperative phase.
timeFrame: Intraoperative
measure: Procedure-related costs
timeFrame: From surgical procedure up to 90 days after surgery
Other outcomes:
Locations:
city: Verona
country: Italy
facility: General and Upper GI Unit
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.