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

• Sponsor: University of Birmingham (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04647188
• Collaborator: Newcastle-upon-Tyne Hospitals NHS Trust (Other), Imperial College Healthcare NHS Trust (Other), Barts & The London NHS Trust (Other), Portsmouth Hospitals NHS Trust (Other), 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), NHS Greater Glasgow and Clyde (Other), Intuitive Surgical (Industry), University Hospitals, Leicester (Other), Sheffield Teaching Hospitals NHS Foundation Trust (Other), Golden Jubilee National Hospital (Other)
• Enrollment: 500
• Locations: 13
• Anticipated Duration (Months): 15.7
• Patients Per Site: 38.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer; Surgery	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Measuring the Quality of Surgical Care and Setting Benchmarks for Training Using Intuitive Data Recorder Technology
• Actual Study Start Date: Mar 9, 2021
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	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
Thoracic group Includes patients undergoing lobectomy (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
Ear, Nose & Throat group Includes patients undergoing tongue base mucosectomy (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

Outcome Measures

Primary Outcome Measures

1. Number of patients with surgical complication [Day 30 after surgery]

   Surgical complication rate at day-30

Other Outcome Measures

1. Total operating time per surgery [During the surgery]

   Intraoperative outcome - total operating time in hours

2. Number of patients with blood loss greater than 500mls during surgery [During the surgery]

   Intraoperative outcome - total blood loss

3. Number of patients with adverse events reported at day 30 [Day 30 after surgery]

   Adverse events rate

4. Total hospital length of stay at day 30 [Day 30 after surgery]

   Hospital length of stay

5. Number of patients with readmission at day 30 [Day 30 after surgery]

   Readmission rate

6. Time to complete cardinal steps in minutes [During the surgery]

   Time taken by surgeon to complete each surgery cardinal step

7. 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")

8. Oncological parameter - tumour stage [Baseline]

   Tumour stage defined by the TNM staging system

9. Number of robotic assisted surgeries carried out by surgeon prior to enrollment in study [Baseline]

   Surgeon's caseload prior surgery

10. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Coventry & Warwickshire NHS Trust	Coventry		United Kingdom
2	Golden Jubilee National Hospital	Glasgow		United Kingdom	G81 4DY
3	Leeds Teaching Hospitals NHS Trust	Leeds		United Kingdom	LS9 7TF
4	University Hospitals of Leicester NHS Trust	Leicester		United Kingdom	LE5 4PW
5	Barts Health NHS Trust	London		United Kingdom	EC1A 7BE
6	Guy's and St Thomas' NHS Foundation Trust	London		United Kingdom	SE1 9RS
7	The Royal Marsden Hospital	London		United Kingdom	SW3 6JJ
8	The Christie NHS Foundation Trust	Manchester		United Kingdom	M20 4BX
9	South Tees NHS Foundation Trust	Middlesbrough		United Kingdom	TS4 3BW
10	Newcastle Hospitals NHS Foundation Trust	Newcastle upon Tyne		United Kingdom	NE7 7DN
11	Portsmouth Hospitals NHS Trust, UK	Portsmouth		United Kingdom	PO6 3LY
12	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield		United Kingdom	S10 2JF
13	Wirral University Teaching Hospital NHS Foundation Trust	Wirral		United Kingdom	CH49 5PE

Sponsors and Collaborators

• University of Birmingham
• 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
• NHS Greater Glasgow and Clyde
• Intuitive Surgical
• University Hospitals, Leicester
• Sheffield Teaching Hospitals NHS Foundation Trust
• Golden Jubilee National Hospital

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Birmingham
• ClinicalTrials.gov Identifier: NCT04647188
• Other Study ID Numbers: RG_19-041
• First Posted: Nov 30, 2020
• Last Update Posted: Sep 30, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Birmingham: Robotic assisted surgery (RAS)

Study Results

No Results Posted as of Sep 30, 2021