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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04647188
Other study ID # RG_19-041
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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