Versius机器人辅助腹股沟疝修补手术临床研究
前瞻性临床研究评估Versius机器人辅助腹股沟疝修补手术的安全性和有效性
The objective of this clinical trial is to evaluate the safety and efficacy of Versius in Inguinal Hernia repair surgery
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Mark Slack, MD
- 电话号码：+44 7766 024389
- 邮箱：mark.slack@cmrsurgical.com
研究联系人备份
- 姓名：Diana Toderita, PhD
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult patients 22 years of age and older, deemed eligible for elective minimal invasive inguinal Hernia repair surgery.
- Patients providing written informed consent to participate in the study.
Exclusion Criteria:
- Patient unwilling to provide informed consent.
- Medical contraindication for general anaesthesia or minimally invasive procedure.
- Patient participation in an interventional clinical study that could impact primary outcomes results.
- Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above.
- Patients undergoing a concomitant surgical procedure.
- Contraindication for undergoing surgery with Versius (bleeding diathesis, active pregnancy or BMI ≥40 kg/m2).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Versius手术
|
Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Success rate
大体时间：Up to completion of surgery
|
Rate of successful completion of robotic assisted surgery as planned without unplanned conversion to other laparoscopic or open surgery |
Up to completion of surgery
|
|
Serious Adverse Event rate
大体时间：Up to 30 days post procedure
|
Rate of total procedure related serious adverse events |
Up to 30 days post procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
死亡率
大体时间：术后最多30天
|
术后最多30天
|
|
|
Operative time
大体时间：Up to completion of surgery
|
Surgical time from skin incision to skin closure |
Up to completion of surgery
|
|
Estimated blood loss
大体时间：Up to completion of surgery
|
Amount of blood estimated to be lost during surgery (in mL) |
Up to completion of surgery
|
|
Intra-operative adverse events
大体时间：Up to completion of surgery
|
Adverse events that occur during surgery |
Up to completion of surgery
|
|
Blood transfusion
大体时间：Up to completion of surgery
|
Need for blood transfusion during surgery as well as amount transfused |
Up to completion of surgery
|
|
Device deficiencies
大体时间：Up to completion of surgery
|
Any device deficiencies of Versius during surgery |
Up to completion of surgery
|
|
Reoperation within 24 hours
大体时间：24 hours post-surgery
|
Need for reoperation after initial surgery |
24 hours post-surgery
|
|
Length of hospital stay
大体时间：Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days
|
Hospital stay in days from day of surgery until discharge |
Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days
|
|
Adverse events
大体时间：Up to 30 days post-surgery
|
Rate of adverse events |
Up to 30 days post-surgery
|
|
Readmission
大体时间：Up to 30 days post-surgery
|
Hospital readmission after post-surgical discharge |
Up to 30 days post-surgery
|
|
Reoperation within 30 days
大体时间：Up to 30 days post-surgery
|
Need for reoperation as a result of interventional surgery itself or the indication for surgery |
Up to 30 days post-surgery
|
合作者和调查者
调查人员
- 首席研究员：Bruno Domenico Antonio Alampi, MD、Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan
- 首席研究员：Jaime Lopez Borao, MD、Hospital Universitari de Bellvitge
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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