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

Cancer Clinical Trial

— MASTERY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04647188
• Other study ID #: RG_19-041
• Status: Active, not recruiting
• Start date: March 9, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: May 2023
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: October 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Surgery

Intervention

Other:
• Robotic assisted surgery with IDR data capture
Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology

Locations

Country	Name	City	State
United Kingdom	University Hospitals Coventry & Warwickshire NHS Trust	Coventry
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	Royal Surrey NHS Foundation Trust	Guildford
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	The Royal Marsden Hospital	London
United Kingdom	The Royal Marsden NHS Foundation Trust	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	South Tees NHS Foundation Trust	Middlesbrough
United Kingdom	Newcastle Hospitals NHS Foundation Trust	Newcastle upon Tyne
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	Portsmouth Hospitals NHS Trust, UK	Portsmouth
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United Kingdom	Wirral University Teaching Hospital NHS Foundation Trust	Wirral

Sponsors (18)

Lead Sponsor

Collaborator

University of Birmingham

Barts & The London NHS Trust, Golden Jubilee National Hospital, Guy's and St Thomas' NHS Foundation Trust, Imperial College Healthcare NHS Trust, Intuitive Surgical, Newcastle-upon-Tyne Hospitals NHS Trust, Oxford University Hospitals NHS Trust, Portsmouth Hospitals NHS Trust, Royal Marsden NHS Foundation Trust, Royal Surrey County Hospital NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust, The Christie NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, University Hospitals Coventry and Warwickshire NHS Trust, University Hospitals, Leicester, Wirral University Teaching Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total operating time per surgery	Intraoperative outcome - total operating time in hours	During the surgery
Other	Number of patients with blood loss greater than 500mls during surgery	Intraoperative outcome - total blood loss	During the surgery
Other	Number of patients with adverse events reported at day 30	Adverse events rate	Day 30 after surgery
Other	Total hospital length of stay at day 30	Hospital length of stay	Day 30 after surgery
Other	Number of patients with readmission at day 30	Readmission rate	Day 30 after surgery
Other	Time to complete cardinal steps in minutes	Time taken by surgeon to complete each surgery cardinal step	During the surgery
Other	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
Other	Oncological parameter - tumour stage	Tumour stage defined by the TNM staging system	Baseline
Other	Number of robotic assisted surgeries carried out by surgeon prior to enrollment in study	Surgeon's caseload prior surgery	Baseline
Other	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
Primary	Number of patients with surgical complication	Surgical complication rate at day-30	Day 30 after surgery