CancerMASTERYNCT04647188
Measuring the Quality of Surgical Care and Setting Benchmarks for Training Using Intuitive Data Recorder Technology
An observational study of Cancer and Surgery, run by University of Birmingham at 15 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- What is being tested?
- Robotic assisted surgery with IDR data capture
- How many people
- 500 participants
- Where
- 15 sitesUnited Kingdom
- Study dates
- 9 Mar 2021to 31 Oct 2023
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include patients undergoing robotic assisted surgery for .prostate, colorectal, lung, gynaecological, hepatobiliary, and ear, nose and throat tumours
Who may be able to join
- 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
Who cannot join
- Age < 16years
- Patients undergoing robotic surgery for other indications not relevant to the study
- Patients not consenting to data capture
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United Kingdom15 sites
University Hospitals Coventry & Warwickshire NHS Trust
Coventry
Golden Jubilee National Hospital
Glasgow, G81 4DY
Royal Surrey NHS Foundation Trust
Guildford, GU2 7XX
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Barts Health NHS Trust
London, EC1A 7BE
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RS
The Royal Marsden Hospital
London, SW3 6JJ
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
The Christie NHS Foundation Trust
Manchester, M20 4BX
Wirral University Teaching Hospital NHS Foundation Trust
Metropolitan Borough of Wirral, CH49 5PE
South Tees NHS Foundation Trust
Middlesbrough, TS4 3BW
Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
Oxford University Hospitals NHS Foundation Trust
Oxford
Portsmouth Hospitals NHS Trust, UK
Portsmouth, PO6 3LY
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
About this study
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.
Read the 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.
- Being tested
- Robotic assisted surgery with IDR data capture
- Keywords
- Robotic assisted surgery (RAS)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted surgery with IDR data captureOther
Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology
| Study group | Role | What they receive |
|---|---|---|
| Urology group | Includes patients undergoing prostatectomy (n=100) Receives: Other: Robotic assisted surgery with IDR data capture | |
| Colorectal group | Includes patients undergoing anterior rectal resection (n=100) Receives: Other: Robotic assisted surgery with IDR data capture | |
| Thoracic group | Includes patients undergoing lobectomy or segmentectomy (n=100) Receives: Other: Robotic assisted surgery with IDR data capture | |
| Gynaecological group | Includes patients undergoing hysterectomy (n=100) Receives: Other: Robotic assisted surgery with IDR data capture | |
| HpB group | Includes pancreatic tumour resection patients (n=50) Receives: Other: Robotic assisted surgery with IDR data capture | |
| Ear, Nose & Throat group | Includes patients undergoing lateral oropharyngectomy (n=50) Receives: Other: Robotic assisted surgery with IDR data capture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with surgical complication
Surgical complication rate at day-30
Measured: Day 30 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start9 Mar 2021
- Primary completion30 Jun 2023
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Simon Bach, Principal investigator, University of Birmingham; Royal College of Surgeons UK Robotics GroupNaeem Soomro, Principal investigator, Newcastle-Upon-Tyne Hospitals NHS Trust; Royal College of Surgeons UK Robotics Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647188
- Sponsor's protocol ID
- RG_19-041
- Acronym
- MASTERY
- Status last verified
- May 2023
- First submitted
- 8 Oct 2020
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Quality of Surgical Care and Setting Benchmarks for Training Using Intuitive Data Recorder Technology
- ClinicalTrials.gov ID
- NCT04647188
- Acronym / sponsor ID
- MASTERY / RG_19-041
- Keywords
- Robotic assisted surgery (RAS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- 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
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Urology group | – | Other: Robotic assisted surgery with IDR data captureIncludes patients undergoing prostatectomy (n=100) |
| Colorectal group | – | Other: Robotic assisted surgery with IDR data captureIncludes patients undergoing anterior rectal resection (n=100) |
| Thoracic group | – | Other: Robotic assisted surgery with IDR data captureIncludes patients undergoing lobectomy or segmentectomy (n=100) |
| Gynaecological group | – | Other: Robotic assisted surgery with IDR data captureIncludes patients undergoing hysterectomy (n=100) |
| HpB group | – | Other: Robotic assisted surgery with IDR data captureIncludes pancreatic tumour resection patients (n=50) |
| Ear, Nose & Throat group | – | Other: Robotic assisted surgery with IDR data captureIncludes patients undergoing lateral oropharyngectomy (n=50) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include patients undergoing robotic assisted surgery for .prostate, colorectal, lung, gynaecological, hepatobiliary, and ear, nose and throat tumours
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 16years
- Patients undergoing robotic surgery for other indications not relevant to the study
- Patients not consenting to data capture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic assisted surgery with IDR data captureRobotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology | Other | Colorectal group, Ear, Nose & Throat group, Gynaecological group, HpB group, Thoracic group, Urology group |
Primary outcome
Number of patients with surgical complication
Time frame: Day 30 after surgery
Surgical complication rate at day-30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Bach principal investigator
University of Birmingham; Royal College of Surgeons UK Robotics Group
Naeem Soomro principal investigator
Newcastle-Upon-Tyne Hospitals NHS Trust; Royal College of Surgeons UK Robotics Group
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Surgery, run by University of Birmingham at 15 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with surgical complication (time frame: Day 30 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.