Clinical trial NCT04647188: Measuring the Quality of Surgical Care and Setting Benchmarks for Training Using Intuitive Data Recorder Technology
Official title: Measuring the Quality of Surgical Care and Setting Benchmarks for Training Using Intuitive Data Recorder Technology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Surgery
Keywords: Robotic assisted surgery (RAS)
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Newcastle-upon-Tyne Hospitals NHS Trust
name: Imperial College Healthcare NHS Trust
name: Barts & The London NHS Trust
name: Portsmouth Hospitals NHS Trust
name: Royal Marsden NHS Foundation Trust
name: Wirral University Teaching Hospital NHS Trust
name: The Leeds Teaching Hospitals NHS Trust
name: Guy's and St Thomas' NHS Foundation Trust
name: South Tees Hospitals NHS Foundation Trust
name: University Hospitals Coventry and Warwickshire NHS Trust
name: Intuitive Surgical
name: University Hospitals, Leicester
name: Sheffield Teaching Hospitals NHS Foundation Trust
name: Golden Jubilee National Hospital
name: Royal Surrey County Hospital NHS Foundation Trust
name: Oxford University Hospitals NHS Trust
name: The Christie NHS Foundation Trust
First posted: 2020-11-30
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with surgical complication
timeFrame: Day 30 after surgery
Secondary outcomes:
Other outcomes:
measure: Total operating time per surgery
timeFrame: During the surgery
measure: Number of patients with blood loss greater than 500mls during surgery
timeFrame: During the surgery
measure: Number of patients with adverse events reported at day 30
timeFrame: Day 30 after surgery
measure: Total hospital length of stay at day 30
timeFrame: Day 30 after surgery
measure: Number of patients with readmission at day 30
timeFrame: Day 30 after surgery
measure: Time to complete cardinal steps in minutes
timeFrame: During the surgery
measure: Number of patients with complete or incomplete surgical resection
timeFrame: During the surgery
measure: Oncological parameter - tumour stage
timeFrame: Baseline
measure: Number of robotic assisted surgeries carried out by surgeon prior to enrollment in study
timeFrame: Baseline
measure: Patient reported outcomes
timeFrame: Baseline, day 30 and day 90 after surgery
Locations:
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwickshire NHS Trust
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Guildford
country: United Kingdom
facility: Royal Surrey NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Middlesbrough
country: United Kingdom
facility: South Tees NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle Hospitals NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust, UK
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: Wirral
country: United Kingdom
facility: Wirral University Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: University of Birmingham; Royal College of Surgeons UK Robotics Group
name: Simon Bach
role: PRINCIPAL_INVESTIGATOR
affiliation: Newcastle-Upon-Tyne Hospitals NHS Trust; Royal College of Surgeons UK Robotics Group
name: Naeem Soomro
role: PRINCIPAL_INVESTIGATOR
References: