跳至主要内容
临床试验/NCT04647188
NCT04647188进行中(未招募)不适用

Measuring the Quality of Surgical Care and Setting Benchmarks for Training Using Intuitive Data Recorder Technology

University of Birmingham15 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
500
试验地点
15
主要终点
Number of patients with surgical complication

研究概览

简要总结

MASTERY is a multi-centre prospective cohort study involving patients undergoing robotic assisted surgery for prostate, colorectal, lung, gynaecological, hepatobiliary, and ear, nose & throat tumours.

详细描述

MASTERY will create a data collection platform to capture, annotate and analyse digital point of care data relating to surgeon's performance during live surgery. This is a multi-centre prospective cohort study involving patients undergoing robotic assisted surgery for prostate, colorectal, lung, gynaecological, hepatobiliary, and ear, nose & throat tumours. In this study, automated digital point of care data relating to the surgeons' performance will be collected via the Intuitive Data Recorder (IDR) device (Intuitive Surgical Inc, USA). Data collection will also encompass surgeon characteristics, patient characteristics, 30-day clinical outcomes including surgical complications, reoperation, length of stay and hospital readmission. This will also include collection of baseline, 30- and 90-day patient reported outcomes data.

MASTERY is the first study of the RCS Robotics Working Group and aims to initially recruit 500 patients across 13 centres in United Kingdom from January 2021.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >= 16years
  • Patients undergoing robotic assisted surgery for prostate, colorectal, lung, gynaecological, hepatobiliary, and ENT tumours
  • Patients consenting to data collection who are scheduled to undergo robotic assisted surgery

排除标准

  • Age < 16years
  • Patients undergoing robotic surgery for other indications not relevant to the study
  • Patients not consenting to data capture

结局指标

主要结局

Number of patients with surgical complication

时间窗: Day 30 after surgery

Surgical complication rate at day-30

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (15)

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