Measuring the Quality of Surgical Care and Setting Benchmarks for Training Using Intuitive Data Recorder Technology (MASTERY)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer; Surgery
• Intervention / Treatment: Other: Robotic assisted surgery with IDR data capture

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: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• United Kingdom
  • Coventry, United Kingdom
    • University Hospitals Coventry & Warwickshire NHS Trust
  • Glasgow, United Kingdom, G81 4DY
    • Golden Jubilee National Hospital
  • Guildford, United Kingdom, GU2 7XX
    • Royal Surrey NHS Foundation Trust
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hospitals NHS Trust
  • London, United Kingdom, EC1A 7BE
    • Barts Health NHS Trust
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden Hospital
  • London, United Kingdom, SE1 9RS
    • Guy's and St Thomas' NHS Foundation Trust
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust
  • Middlesbrough, United Kingdom, TS4 3BW
    • South Tees NHS Foundation Trust
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Newcastle Hospitals NHS Foundation Trust
  • Oxford, United Kingdom
    • Oxford University Hospitals NHS Foundation Trust
  • Portsmouth, United Kingdom, PO6 3LY
    • Portsmouth Hospitals NHS Trust, UK
  • Sheffield, United Kingdom, S10 2JF
    • Sheffield Teaching Hospitals NHS Foundation Trust
  • Wirral, United Kingdom, CH49 5PE
    • Wirral University Teaching Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will include patients undergoing robotic assisted surgery for .prostate, colorectal, lung, gynaecological, hepatobiliary, and ear, nose and throat tumours

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

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Urology group; Includes patients undergoing prostatectomy (n=100)	Other: Robotic assisted surgery with IDR data capture; Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology
Colorectal group; Includes patients undergoing anterior rectal resection (n=100)	Other: Robotic assisted surgery with IDR data capture; Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology
Gynaecological group; Includes patients undergoing hysterectomy (n=100)	Other: Robotic assisted surgery with IDR data capture; 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)	Other: Robotic assisted surgery with IDR data capture; 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)	Other: Robotic assisted surgery with IDR data capture; Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology
Ear, Nose & Throat group; Includes patients undergoing lateral oropharyngectomy (n=50)	Other: Robotic assisted surgery with IDR data capture; Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with surgical complication	Surgical complication rate at day-30	Day 30 after surgery

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Birmingham
• Collaborators: Royal Marsden NHS Foundation Trust; The Leeds Teaching Hospitals NHS Trust; Guy's and St Thomas' NHS Foundation Trust; Sheffield Teaching Hospitals NHS Foundation Trust; Barts & The London NHS Trust; University Hospitals, Leicester; Newcastle-upon-Tyne Hospitals NHS Trust; Portsmouth Hospitals NHS Trust; Intuitive Surgical; The Christie NHS Foundation Trust; Oxford University Hospitals NHS Trust; Imperial College Healthcare NHS Trust; University Hospitals Coventry and Warwickshire NHS Trust; South Tees Hospitals NHS Foundation Trust; Golden Jubilee National Hospital; Royal Surrey County Hospital NHS Foundation Trust; Wirral University Teaching Hospital NHS Trust
• 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): March 9, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): October 31, 2023

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Robotic assisted surgery (RAS)
• Other Study ID Numbers: RG_19-041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No