Measuring the Quality of Surgical Care and Setting Benchmarks for Training Using Intuitive Data Recorder Technology (MASTERY)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Coventry, United Kingdom
- University Hospitals Coventry & Warwickshire NHS Trust
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Glasgow, United Kingdom, G81 4DY
- Golden Jubilee National Hospital
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Guildford, United Kingdom, GU2 7XX
- Royal Surrey NHS Foundation Trust
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Leeds, United Kingdom, LS9 7TF
- Leeds Teaching Hospitals NHS Trust
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London, United Kingdom, EC1A 7BE
- Barts Health NHS Trust
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London, United Kingdom, SW3 6JJ
- The Royal Marsden NHS Foundation Trust
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London, United Kingdom, SW3 6JJ
- The Royal Marsden Hospital
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London, United Kingdom, SE1 9RS
- Guy's and St Thomas' NHS Foundation Trust
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Manchester, United Kingdom, M20 4BX
- The Christie NHS Foundation Trust
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Middlesbrough, United Kingdom, TS4 3BW
- South Tees NHS Foundation Trust
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Newcastle upon Tyne, United Kingdom, NE7 7DN
- Newcastle Hospitals NHS Foundation Trust
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Oxford, United Kingdom
- Oxford University Hospitals NHS Foundation Trust
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Portsmouth, United Kingdom, PO6 3LY
- Portsmouth Hospitals NHS Trust, UK
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Sheffield, United Kingdom, S10 2JF
- Sheffield Teaching Hospitals NHS Foundation Trust
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Wirral, United Kingdom, CH49 5PE
- Wirral University Teaching Hospital NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Age < 16years
- Patients undergoing robotic surgery for other indications not relevant to the study
- Patients not consenting to data capture
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Urology group
Includes patients undergoing prostatectomy (n=100)
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Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology
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Colorectal group
Includes patients undergoing anterior rectal resection (n=100)
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Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology
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|
Gynaecological group
Includes patients undergoing hysterectomy (n=100)
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Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology
|
|
HpB group
Includes pancreatic tumour resection patients (n=50)
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Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology
|
|
Thoracic group
Includes patients undergoing lobectomy or segmentectomy (n=100)
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Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology
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|
Ear, Nose & Throat group
Includes patients undergoing lateral oropharyngectomy (n=50)
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Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with surgical complication
Time Frame: Day 30 after surgery
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Surgical complication rate at day-30
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Day 30 after surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total operating time per surgery
Time Frame: During the surgery
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Intraoperative outcome - total operating time in hours
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During the surgery
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Number of patients with blood loss greater than 500mls during surgery
Time Frame: During the surgery
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Intraoperative outcome - total blood loss
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During the surgery
|
|
Number of patients with adverse events reported at day 30
Time Frame: Day 30 after surgery
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Adverse events rate
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Day 30 after surgery
|
|
Total hospital length of stay at day 30
Time Frame: Day 30 after surgery
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Hospital length of stay
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Day 30 after surgery
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Number of patients with readmission at day 30
Time Frame: Day 30 after surgery
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Readmission rate
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Day 30 after surgery
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|
Time to complete cardinal steps in minutes
Time Frame: During the surgery
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Time taken by surgeon to complete each surgery cardinal step
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During the surgery
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Number of patients with complete or incomplete surgical resection
Time Frame: During the surgery
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Intraoperative outcome - completeness of surgical resection (defined by the surgeon as "complete" or "incomplete")
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During the surgery
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Oncological parameter - tumour stage
Time Frame: Baseline
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Tumour stage defined by the TNM staging system
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Baseline
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Number of robotic assisted surgeries carried out by surgeon prior to enrollment in study
Time Frame: Baseline
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Surgeon's caseload prior surgery
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Baseline
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Patient reported outcomes
Time Frame: Baseline, day 30 and day 90 after surgery
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Patient's global assessment of quality of life via the EORTC QLQ-C30 and the specialty specific modules (PR25, LC29, EN24, CR29, H&N43) All of the scales and single-item measures range in score from 0 to 100. A high score for the Sexual Activity and Sexual Functioning scales represents a high level of functioning, whereas a high score for the Urinary, Bowel, and Hormonal Treatment-Related symptoms scales and Incontinence Aid item represents a high level of symptomatology or problems. |
Baseline, day 30 and day 90 after surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Simon Bach, University of Birmingham; Royal College of Surgeons UK Robotics Group
- Principal Investigator: Naeem Soomro, Newcastle-Upon-Tyne Hospitals NHS Trust; Royal College of Surgeons UK Robotics Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RG_19-041
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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