Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy (COMPAR-G) in Gastric Cancer Patient.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Evaluation of surgical times of the standardized procedures (Phase 2)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluation of surgical times of the standardized procedures (Phase 2)
时间窗: Intraoperative
Analysis of surgical times (as minutes of the different surgical steps of the standardized procedure).
Conversion rate to open or laparoscopic approach (Phase 1)
时间窗: Intraoperative
Number of procedures in which it is necessary to convert to open or laparoscopic approach, due to surgical and/or oncological needs
Number of participants with major intraoperative complications (Phase 1)
时间窗: Intraoperative
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.
Analysis of video of surgical procedures (Phase 2)
时间窗: Intraoperative
Evaluation of analysis of video of surgical procedure, as deviations from the standard.
次要结局
- Postoperative pain(1-5 days postoperative)
- Postoperative hospitalization(From the surgery day up to 20 days postoperative)
- Damage due to positioning(Intraoperative)
- Non-Technical Skills Assessment (NTS) demonstrated by members of the surgical team during the intraoperative phase.(Intraoperative)
- Re-admission rate to hospitalization(Up to 90 days postoperative)
- Positive Surgical Margin(Up to 2 weeks postoperative (during histological analysis))
- Lymph nodes resection(Up to 2 weeks postoperative (during histological analysis))
- Possible malfunction of the platform(Intraoperative)
- 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)
- Time taken for platform-related technical steps(From the room setting, through surgical procedure until postoperative room restoration for each of expected surgeries)
- Compliance rate to ERAS protocol(1-7 days postoperative)
- Procedure-related costs(From surgical procedure up to 90 days after surgery)
- Quality of Life Evaluation(Postoperaive (follow up at 1 month))