Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy

Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy (COMPAR-G) in Gastric Cancer Patient.

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Gastric Cancer; Gastrointestinal Cancer; Gastric Neoplasm; Stomach Adenocarcinoma; Gastric Diffuse Adenocarcinoma
• Intervention / Treatment: Device: DaVinci® Surgical System; Device: Hugo™ RAS System; Device: Versius® Robotic Surgery System

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simone SG Giacopuzzi, MD, Prof; Phone Number: +39 0458127510; Email: simone.giacopuzzi@univr.it

Study Locations

• Italy
  • Verona, Italy, 37126
    • Recruiting
    • General and Upper GI Unit
    • Contact: Simone SG Giacopuzzi, MD, Prof; Phone Number: +39 0458127510; Email: simone.giacopuzzi@univr.it
    • Principal Investigator: Simone Giacopuzzi, MD, Prof
    • Sub-Investigator: Maria Bencivenga, MD, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DaVinci® Surgical System; 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)	Device: DaVinci® Surgical System; Assisted-robotic radical Gastrectomy
Experimental: Hugo™ RAS System; 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)	Device: Hugo™ RAS System; Assisted-robotic radical Gastrectomy
Experimental: Versius® Robotic Surgery System; 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)	Device: Versius® Robotic Surgery System; Assisted-robotic radical Gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall duration of the surgery	Minutes	Intraoperative
Possible malfunction of the platform	Note	Intraoperative
Estimated Blood Loss	Volume of blood loss (ml)	Intraoperative
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
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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Actual): March 30, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative complications; Robotic-assisted surgery; Gastrectomy; Operative outcomes; Multiple surgical platforms
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Neoplasms; Stomach Neoplasms; Adenocarcinoma; Gastrointestinal Neoplasms
• Other Study ID Numbers: COMPAR-G

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes