Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Diffuse Adenocarcinoma | Gastric Diffuse Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Neoplasm | Gastric Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Stomach Adenocarcinoma | Gastric Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DaVinci® Surgical System | Device | — | UNRESOLVED |
| Hugo™ RAS System | Device | — | UNRESOLVED |
| Versius® Robotic Surgery System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- DaVinci® Surgical System
- description
- 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)
- interventionNames
- Device: DaVinci® Surgical System
- type
- EXPERIMENTAL
- label
- Hugo™ RAS System
- description
- 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)
- interventionNames
- Device: Hugo™ RAS System
- type
- EXPERIMENTAL
- label
- Versius® Robotic Surgery System
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (7)
- RESULTHaig 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
- RESULTPeters 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
- RESULTSolaini 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
- RESULTLi 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
- RESULTShibasaki 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
- RESULTPrata 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
- RESULTBaiocchi 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.