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

University of Birmingham

Status: Active, not recruiting

Conditions: Surgery; Cancer

Treatments: Other: Robotic assisted surgery with IDR data capture

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04647188

RG_19-041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 6 patient groups

Urology group

Description:

Includes patients undergoing prostatectomy (n=100)

Treatment:

Other: Robotic assisted surgery with IDR data capture

Colorectal group

Description:

Includes patients undergoing anterior rectal resection (n=100)

Treatment:

Other: Robotic assisted surgery with IDR data capture

Thoracic group

Description:

Includes patients undergoing lobectomy or segmentectomy (n=100)

Treatment:

Other: Robotic assisted surgery with IDR data capture

Gynaecological group

Description:

Includes patients undergoing hysterectomy (n=100)

Treatment:

Other: Robotic assisted surgery with IDR data capture

HpB group

Description:

Includes pancreatic tumour resection patients (n=50)

Treatment:

Other: Robotic assisted surgery with IDR data capture

Ear, Nose & Throat group

Description:

Includes patients undergoing lateral oropharyngectomy (n=50)

Treatment:

Other: Robotic assisted surgery with IDR data capture