Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy

NCT06362070 | Recruiting DMC FDA Device

• 1 other identifier: COMPAR-G
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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:
• surgery with the daVinci platform;
• surgery with the Hugo platform;
• surgery with the Versius platform.

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• Estimated Blood Loss

  Intraoperative

• Overall duration of the surgery

  Intraoperative

• Anesthesia, Lymphadenectomy, Gastrectomy (10 different surgical steps)

  Entrance of patient into operating room until completion of surgery

• Number of participants with major postoperative complications

  Until 90 days post surgery

• Compliance rate to ERAS protocol

  1-7 days postoperative

Study Arms (3)

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)

Device: DaVinci® Surgical System

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)

Device: Hugo™ RAS System

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)

Device: Versius® Robotic Surgery System

Interventions

DaVinci® Surgical System DEVICE

Assisted-robotic radical Gastrectomy

DaVinci® Surgical System

Hugo™ RAS System DEVICE

Assisted-robotic radical Gastrectomy

Hugo™ RAS System

Versius® Robotic Surgery System DEVICE

Assisted-robotic radical Gastrectomy

Versius® Robotic Surgery System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

General and Upper GI Unit

Verona, 37126, Italy

RECRUITING

Related Publications (7)

• 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.

  PMID: 35047788 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.

  PMID: 29442240 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.

  PMID: 33340239 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.

  PMID: 35472517 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.

  PMID: 37010634 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.

  PMID: 37623483 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.

  PMID: 29846827 RESULT

MeSH Terms

Conditions

Stomach Neoplasms; Gastrointestinal Neoplasms; Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Simone SG Giacopuzzi, MD, Prof

CONTACT

+39 0458127510; simone.giacopuzzi@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 12, 2024
• Study Start: January 31, 2024
• Primary Completion: March 30, 2024
• Study Completion: July 31, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)