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| Name | Class |
|---|---|
| Newcastle-upon-Tyne Hospitals NHS Trust | OTHER |
| Imperial College Healthcare NHS Trust | OTHER |
| Barts & The London NHS Trust | OTHER |
| Portsmouth Hospitals NHS Trust |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urology group | Includes patients undergoing prostatectomy (n=100) |
| |
| Colorectal group | Includes patients undergoing anterior rectal resection (n=100) |
| |
| Thoracic group | Includes patients undergoing lobectomy or segmentectomy (n=100) |
| |
| Gynaecological group | Includes patients undergoing hysterectomy (n=100) |
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| HpB group | Includes pancreatic tumour resection patients (n=50) |
| |
| Ear, Nose & Throat group | Includes patients undergoing lateral oropharyngectomy (n=50) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic assisted surgery with IDR data capture | Other | Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with surgical complication | Surgical complication rate at day-30 | Day 30 after surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Total operating time per surgery | Intraoperative outcome - total operating time in hours | During the surgery |
| Number of patients with blood loss greater than 500mls during surgery | Intraoperative outcome - total blood loss |
Inclusion Criteria:
Exclusion Criteria:
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The study will include patients undergoing robotic assisted surgery for .prostate, colorectal, lung, gynaecological, hepatobiliary, and ear, nose and throat tumours
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Coventry & Warwickshire NHS Trust | Coventry | United Kingdom | ||||
| Golden Jubilee National Hospital |
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| OTHER_GOV |
| Royal Marsden NHS Foundation Trust | OTHER |
| Wirral University Teaching Hospital NHS Trust | OTHER |
| The Leeds Teaching Hospitals NHS Trust | OTHER |
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
| South Tees Hospitals NHS Foundation Trust | OTHER |
| University Hospitals Coventry and Warwickshire NHS Trust | OTHER |
| Intuitive Surgical | INDUSTRY |
| University Hospitals, Leicester | OTHER |
| Sheffield Teaching Hospitals NHS Foundation Trust | OTHER |
| Golden Jubilee National Hospital | OTHER_GOV |
| Royal Surrey County Hospital NHS Foundation Trust | OTHER |
| Oxford University Hospitals NHS Trust | OTHER |
| The Christie NHS Foundation Trust | OTHER |
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| During the surgery |
| Number of patients with adverse events reported at day 30 | Adverse events rate | Day 30 after surgery |
| Total hospital length of stay at day 30 | Hospital length of stay | Day 30 after surgery |
| Number of patients with readmission at day 30 | Readmission rate | Day 30 after surgery |
| Time to complete cardinal steps in minutes | Time taken by surgeon to complete each surgery cardinal step | During the surgery |
| Number of patients with complete or incomplete surgical resection | Intraoperative outcome - completeness of surgical resection (defined by the surgeon as "complete" or "incomplete") | During the surgery |
| Oncological parameter - tumour stage | Tumour stage defined by the TNM staging system | Baseline |
| Number of robotic assisted surgeries carried out by surgeon prior to enrollment in study | Surgeon's caseload prior surgery | Baseline |
| Patient reported outcomes | 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 |
| Glasgow |
| G81 4DY |
| United Kingdom |
| Royal Surrey NHS Foundation Trust | Guildford | GU2 7XX | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7TF | United Kingdom |
| Barts Health NHS Trust | London | EC1A 7BE | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 9RS | United Kingdom |
| The Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| The Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Wirral University Teaching Hospital NHS Foundation Trust | Metropolitan Borough of Wirral | CH49 5PE | United Kingdom |
| South Tees NHS Foundation Trust | Middlesbrough | TS4 3BW | United Kingdom |
| Newcastle Hospitals NHS Foundation Trust | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | United Kingdom |
| Portsmouth Hospitals NHS Trust, UK | Portsmouth | PO6 3LY | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | S10 2JF | United Kingdom |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
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