Cancer, Surgery
Conditions
Keywords
Robotic assisted surgery (RAS)
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.
Interventions
OTHERRobotic assisted surgery with IDR data capture
Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology
Sponsors
Newcastle-upon-Tyne Hospitals NHS Trust
Imperial College Healthcare NHS Trust
Barts & The London NHS Trust
Portsmouth Hospitals NHS Trust
Royal Marsden NHS Foundation Trust
Wirral University Teaching Hospital NHS Trust
The Leeds Teaching Hospitals NHS Trust
Guy's and St Thomas' NHS Foundation Trust
South Tees Hospitals NHS Foundation Trust
University Hospitals Coventry and Warwickshire NHS Trust
Intuitive Surgical
University Hospitals, Leicester
Sheffield Teaching Hospitals NHS Foundation Trust
Golden Jubilee National Hospital
Royal Surrey County Hospital NHS Foundation Trust
Oxford University Hospitals NHS Trust
The Christie NHS Foundation Trust
University of Birmingham
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with surgical complication | Day 30 after surgery | Surgical complication rate at day-30 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with blood loss greater than 500mls during surgery | During the surgery | Intraoperative outcome - total blood loss |
| Number of patients with adverse events reported at day 30 | Day 30 after surgery | Adverse events rate |
| Total hospital length of stay at day 30 | Day 30 after surgery | Hospital length of stay |
| Number of patients with readmission at day 30 | Day 30 after surgery | Readmission rate |
| Total operating time per surgery | During the surgery | Intraoperative outcome - total operating time in hours |
| Number of patients with complete or incomplete surgical resection | During the surgery | Intraoperative outcome - completeness of surgical resection (defined by the surgeon as complete or incomplete) |
| Oncological parameter - tumour stage | Baseline | Tumour stage defined by the TNM staging system |
| Number of robotic assisted surgeries carried out by surgeon prior to enrollment in study | Baseline | Surgeon's caseload prior surgery |
| Patient reported outcomes | Baseline, day 30 and day 90 after surgery | 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. |
| Time to complete cardinal steps in minutes | During the surgery | Time taken by surgeon to complete each surgery cardinal step |
Countries
United Kingdom
Outcome results
None listed