MASTERY
Research type
Research Study
Full title
Measuring the quality of surgical care and setting benchmarks for training using Intuitive Data Recorder technology
IRAS ID
273555
Contact name
Naeem Soomro
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
1 years, 8 months, 28 days
Research summary
The Royal College of Surgeons of England Commission on the Future of Surgery investigated changes in surgical therapy over the next two decades. The Commission described how intelligent robotic systems will provide a platform for delivery of consistent high-quality surgery to patient populations.
Surgery will shift from an unmediated ‘analogue state’ where the surgeon directly sees, feels and manipulates patient tissues to a mediated ‘digital state’ where the surgeon operates via a robotic platform that is able to intervene inside the body. A key advantage of the robotic platform is that it provides a unique opportunity to gather digital point of care data relating to the surgeon’s technical performance during an operation and therefore opens the door to objective assessment and benchmarking of surgical proficiency and performance.
MASTERY will create a data collection platform to capture, annotate and analyse digital point of care data relating to surgeon’s performance. 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. 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) during live robotic assisted surgery. Data collection will encompass surgeon characteristics, patient characteristics in addition to 30-day surgical outcomes including complications, reoperation, length of stay, hospital readmission and patient reported outcomes.
The primary goals of this project are to (1) improve surgeon training by defining actionable, task-based metrics that can benchmark technical performance and (2) improve patient outcomes by using task-based metrics to determine optimal procedure workflow and surgeon technical efficiencies.
MASTERY is the first study of the RCS Robotics Working Group and aims to initially recruit 500 patients across 12 centres in United Kingdom.
Lay summary of study results: Who Sponsored this study?
This study was sponsored by the University of Birmingham. The Mastery trials office can be contacted via MASTERY@trials.bham.ac.uk.General information about the trial
What patients were included in this study?
This study was a data-collection study with no study/treatment intervention outside data collection (Imaging, Device data) and direct patient derived data (clinical and patient reported outcomes).
The study including participants that were scheduled to received surgery on specific robotic surgery platforms.Number of participants: 667
Number of evaluable; 435 (number of participants with full complete data sets including IDR data, video data and clinical dataThe study recruited participants that received the following types of surgical procedure
Arm 1: Gynaecology) - 118
(74 evaluable)
Arm 2: Urology - 232
(153 evaluable)
Arm 3: Thoracic - 176
(120 evaluable)
Arm 4: Colorectal - 114
(69 evaluable)
Arm 5: Hepatobiliary - 26
(18 evaluable)
(Arm 6: Head and Neck - 1
(1 evaluable))Which medicine was studied?
Not applicable – surgery intervention data collection study
What were the side effects?
Safety data was collected as part of the clinical data set however due to the type of study (surgery data collection only). Due to the nature of the study and multiple types of surgery it is not applicable to list, the ‘side effect’ here is no specific drug intervention was applicable to this study
What were the overall results of the study?
The study has recruited
Number of participants: 667
Number of evaluable; 435 (number of participants with full complete data sets including IDR data, video data and clinical dataThe study recruited participants that received the following types of surgical procedure
Arm 1: Gynaecology) - 118
(74 evaluable)
Arm 2: Urology - 232
(153 evaluable)
Arm 3: Thoracic - 176
(120 evaluable)
Arm 4: Colorectal - 114
(69 evaluable)
Arm 5: Hepatobiliary - 26
(18 evaluable)
(Arm 6: Head and Neck -1
(1 evaluable))How has this study helped patients and researchers?
The study has provided valuable data set that can be used by researchers in a multiple ways to enhance training modals and develop surgical modals. The study was a data collection platform to collected multifactorial data associated with a particular robotic surgery platform. The study team are now moving onto the next steps to allow the data to be shared /accessed by multiple intuitions, academics and researchers to fully utilise this important data set.
Are there plans for further studies?
At present,There are no further plans for further studies to be led by the University of Birmingham (Sponsor).
Where can I find more information about this study?
To learn about this study, you can find more detailed information can be found on the Clinical trials.Gov database .
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT04647188%2FNBTI%2F9VPHAQ%2FAQ%2Fdc266846-1c64-4ecd-b61e-4e89d31ae0f2%2F1%2FfyXSZdnMKz&data=05%7C02%7Cbloomsbury.rec%40hra.nhs.uk%7Cb44e5366b9f34f7c3b7c08def8656dc6%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639221311687327109%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=rB7MAUgu%2Fe8CjIf4JUBwyUg%2FvRatgczfjuU4CHLTrL0%3D&reserved=0REC name
London - Bloomsbury Research Ethics Committee
REC reference
20/PR/0580
Date of REC Opinion
17 Dec 2020
REC opinion
Further Information Favourable Opinion