Clinical Trials Directory

Trials / Unknown

UnknownNCT04647188

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

Status
Unknown
Phase
Study type
Observational
Enrollment
500 (estimated)
Sponsor
University of Birmingham · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERRobotic assisted surgery with IDR data captureRobotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology

Timeline

Start date
2021-03-09
Primary completion
2023-06-30
Completion
2023-10-31
First posted
2020-11-30
Last updated
2023-09-26

Locations

15 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04647188. Inclusion in this directory is not an endorsement.