NCT04647188

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 9, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

September 26, 2023

Status Verified

May 1, 2023

Enrollment Period

2.3 years

First QC Date

October 8, 2020

Last Update Submit

September 22, 2023

Conditions

Keywords

Robotic assisted surgery (RAS)

Outcome Measures

Primary Outcomes (1)

  • Number of patients with surgical complication

    Surgical complication rate at day-30

    Day 30 after surgery

Other Outcomes (10)

  • Total operating time per surgery

    During the surgery

  • Number of patients with blood loss greater than 500mls during surgery

    During the surgery

  • Number of patients with adverse events reported at day 30

    Day 30 after surgery

  • +7 more other outcomes

Study Arms (6)

Urology group

Includes patients undergoing prostatectomy (n=100)

Other: Robotic assisted surgery with IDR data capture

Colorectal group

Includes patients undergoing anterior rectal resection (n=100)

Other: Robotic assisted surgery with IDR data capture

Thoracic group

Includes patients undergoing lobectomy or segmentectomy (n=100)

Other: Robotic assisted surgery with IDR data capture

Gynaecological group

Includes patients undergoing hysterectomy (n=100)

Other: Robotic assisted surgery with IDR data capture

HpB group

Includes pancreatic tumour resection patients (n=50)

Other: Robotic assisted surgery with IDR data capture

Ear, Nose & Throat group

Includes patients undergoing lateral oropharyngectomy (n=50)

Other: Robotic assisted surgery with IDR data capture

Interventions

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

Colorectal groupEar, Nose & Throat groupGynaecological groupHpB groupThoracic groupUrology group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 16years
  • Patients undergoing robotic surgery for other indications not relevant to the study
  • Patients not consenting to data capture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, G81 4DY, United Kingdom

Location

Royal Surrey NHS Foundation Trust

Guildford, GU2 7XX, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RS, United Kingdom

Location

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Wirral University Teaching Hospital NHS Foundation Trust

Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

Location

South Tees NHS Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

Location

Newcastle Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

Portsmouth Hospitals NHS Trust, UK

Portsmouth, PO6 3LY, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Robotic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Simon Bach

    University of Birmingham; Royal College of Surgeons UK Robotics Group

    PRINCIPAL INVESTIGATOR
  • Naeem Soomro

    Newcastle-Upon-Tyne Hospitals NHS Trust; Royal College of Surgeons UK Robotics Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2020

First Posted

November 30, 2020

Study Start

March 9, 2021

Primary Completion

June 30, 2023

Study Completion

October 31, 2023

Last Updated

September 26, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations