Measuring the Quality of Surgical Care and Setting Benchmarks for Training Using Intuitive Data Recorder Technology
- Conditions
- CancerSurgery
- Interventions
- Other: Robotic assisted surgery with IDR data capture
- Registration Number
- NCT04647188
- Lead Sponsor
- University of Birmingham
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
- Age < 16years
- Patients undergoing robotic surgery for other indications not relevant to the study
- Patients not consenting to data capture
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Gynaecological group Robotic assisted surgery with IDR data capture Includes patients undergoing hysterectomy (n=100) Urology group Robotic assisted surgery with IDR data capture Includes patients undergoing prostatectomy (n=100) Thoracic group Robotic assisted surgery with IDR data capture Includes patients undergoing lobectomy or segmentectomy (n=100) Colorectal group Robotic assisted surgery with IDR data capture Includes patients undergoing anterior rectal resection (n=100) Ear, Nose & Throat group Robotic assisted surgery with IDR data capture Includes patients undergoing lateral oropharyngectomy (n=50) HpB group Robotic assisted surgery with IDR data capture Includes pancreatic tumour resection patients (n=50)
- Primary Outcome Measures
Name Time Method Number of patients with surgical complication Day 30 after surgery Surgical complication rate at day-30
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Golden Jubilee National Hospital
🇬🇧Glasgow, United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust
🇬🇧Coventry, United Kingdom
Royal Surrey NHS Foundation Trust
🇬🇧Guildford, United Kingdom
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
Barts Health NHS Trust
🇬🇧London, United Kingdom
The Royal Marsden Hospital
🇬🇧London, United Kingdom
The Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
South Tees NHS Foundation Trust
🇬🇧Middlesbrough, United Kingdom
Newcastle Hospitals NHS Foundation Trust
🇬🇧Newcastle upon Tyne, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
Portsmouth Hospitals NHS Trust, UK
🇬🇧Portsmouth, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom
Wirral University Teaching Hospital NHS Foundation Trust
🇬🇧Wirral, United Kingdom