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

Study Overview
=================
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.

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

Conditions
-----------------
Cancer, Surgery

Intervention / Treatment
-----------------
* Other: Robotic assisted surgery with IDR data capture


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Urology group<br>Includes patients undergoing prostatectomy (n=100) | Other: Robotic assisted surgery with IDR data capture<br>* Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology<br>|
| Colorectal group<br>Includes patients undergoing anterior rectal resection (n=100) | Other: Robotic assisted surgery with IDR data capture<br>* Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology<br>|
| Thoracic group<br>Includes patients undergoing lobectomy or segmentectomy (n=100) | Other: Robotic assisted surgery with IDR data capture<br>* Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology<br>|
| Gynaecological group<br>Includes patients undergoing hysterectomy (n=100) | Other: Robotic assisted surgery with IDR data capture<br>* Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology<br>|
| HpB group<br>Includes pancreatic tumour resection patients (n=50) | Other: Robotic assisted surgery with IDR data capture<br>* Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology<br>|
| Ear, Nose & Throat group<br>Includes patients undergoing lateral oropharyngectomy (n=50) | Other: Robotic assisted surgery with IDR data capture<br>* Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with surgical complication | Surgical complication rate at day-30 | Day 30 after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Robotic assisted surgery (RAS)