Gastric Cancer Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | July 31, 2025 |
Est. primary completion date | March 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | General and Upper GI Unit | Verona |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria Integrata Verona |
Italy,
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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. — View 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 — View 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. — View 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 Syste — View 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. — View 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: 1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Analysis of video of surgical procedures (Phase 2) | Evaluation of analysis of video of surgical procedure, as deviations from the standard. | Intraoperative | |
Secondary | Estimated Blood Loss | Volume of blood loss (ml) | Intraoperative | |
Secondary | Overall duration of the surgery | Minutes | Intraoperative | |
Secondary | Anesthesia, Lymphadenectomy, Gastrectomy (10 different surgical steps) | Minutes | Entrance of patient into operating room until completion of surgery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Postoperative hospitalization | Days of recovery until the date of release | From the surgery day up to 20 days postoperative | |
Secondary | 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 | |
Secondary | Re-admission rate to hospitalization | Number of patients readmitted to the hospital for postoperative complications | Up to 90 days postoperative | |
Secondary | Damage due to positioning | Number of damage due to positioning on the operating bed, during the surgical procedure | Intraoperative | |
Secondary | Positive Surgical Margin | Positive margin (distal or proximal) at histological examination | Up to 2 weeks postoperative (during histological analysis) | |
Secondary | Lymph nodes resection | Number of lymph nodes removed | Up to 2 weeks postoperative (during histological analysis) | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | Possible malfunction of the platform | Note | Intraoperative | |
Secondary | 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 | |
Secondary | Procedure-related costs | Estimate | From surgical procedure up to 90 days after surgery |
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