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Surgical Research Networks. December 2013. Benefiting from Trials. Improving care for surgical patients Delivering advances in medicine Disseminating best practice. MRC CR07 - Plane of surgery . MRC CR07 3 yr local recurrence by plane of surgery and treatment arm. MP plane.

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Surgical Research Networks

December 2013


Benefiting from Trials

  • Improving care for surgical patients

  • Delivering advances in medicine

  • Disseminating best practice


MRC CR07 - Plane of surgery

MRC CR07 3 yr local recurrence

by plane of surgery and treatment arm

MP plane

10% vs16%

IM plane

4% vs10%

Meso plane

1% vs7%


100

Mesorectal plane

Intramesorectal plane

Muscularis propria plane

75

Percentage

50

25

0

1998

1999

2000

2001

2002

2003

2004

2005

Year

Plane of surgery CRO7


Open studies on the CRN portfolio: 2012-13


Aim

  • Create a large nucleus of research active surgeons across a range of specialties


Building Networks

Trainee Collaboratives:Experience with Surgical Trials 


Background

  • WMRC

  • Gen Surgery-Trainee led research group

  • Clinical research alongside training


Inclusion:All patients undergoing laparotomy

Exclusion:Laparoscopic-assisted surgery

Online randomisation

Blinded wound reviews pre-discharge (5-7 days) and at 30-33 days post-op

Funded by NIHR Research for Patient Benefit programme

ROSSINI

Reduction Of Surgical Site Infection using a Novel Intervention

A randomised controlled trial of a wound-edge protection device to reduce surgical site infection


ROSSINI - Sites

  • Royal Derby Hospital

  • Wrightington,Wigan and Leigh

  • Derriford Hospital, Plymouth

  • Hope Hospital, Salford

  • Royal Devon and Exeter Hospital

  • Medway

  • Maidstone + Tunbridge Wells

  • Torbay

  • St Marks, London

  • Leyton, Mid Cheshire

  • Nottingham University Hospitals

  • Stepping Hill, Stockport

  • University Hospital Birmingham

  • Russells Hall Hospital

  • Walsall Manor Hospital

  • City and Sandwell Hospitals

  • Heartlands and Good Hope Hospitals

  • Warwick Hospital

  • University Hospital North Staffordshire

  • New Cross Hospital Wolverhampton


Published in the BMJ


Inclusion Criteria:

All laparoscopic and open BOWEL surgery for malignant or benign pathology.

Primary objective:

Does pre-operative dexamethasone reduces post-operative nausea and vomiting (PONV) in patients undergoing elective bowel surgery.

Secondary objectives:

Are there are other measurable benefits during recovery from surgery with the use of dexamethasone including quicker return to oral diet and reduced length of stay.

DexamethasoneReduces Emesis After Major Gastrointestinal Surgery


General Surgical Research Collaboratives

Newcastle Surgical Research Collaborative

Scottish Surgical Registrars Research Group


AIM

  • Aim: a national (international), multicentre, audit of appendicectomy

  • Primary outcome: negative appendicectomy rate

  • Secondary outcomes: laparoscopy, adverse events

  • Inclusion: appendicectomy, all ages


Recruitment

  • 95 centres

  • 3326 patients

  • 89 UK centres

  • 6 international centres


Driving trials recruitment


Building the Infrastructure

  • Open new trials

  • Engage clinicians

  • Provide expertise


Clinical Research Initiative Steering Committee

Royal College of Surgeons and partners

Manchester &

Liverpool

NWSTC

Birmingham

BSTC

Bristol

BSTC

Barts

NFORSC

Oxford

SITU

Surgical Specialty Leads

Orthopaedics, Trauma, Neurosurgery, ENT, head and neck, cardiothoracic, Transplantation

Endocrine, Plastics, Colorectal

Consultant + Trainee network 1

Consultant + Trainee network 2

Consultant + Trainee network 3

Consultant + Trainee network 4

Consultant + Trainee network 5

Consultant + Trainee network 6


A new era

  • Specialist trials unit support

  • Specialty leads

    • Developing study groups

    • Developing collaboration

  • Trainee Networks

    • Nationwide

    • Multidisciplinary


Colllaborative team

Train Clinicians

Governance & Ethics

Protocol

MHRA

Randomise

Test Data Sets

First in Man Trials

International Uptake

Regulatory

Administration

Early Phase Study

National Evaluation

Innovator

HTC

Early phase unit

Late Phase Trials Unit


ROCSS: Reinforcement of Closure of Stoma Site


Technique

  • Technique published

  • Youtube: http://www.youtube.com/watch?v=v7gtLWLzBkY


ROCSS timelines

  • Phase 1 2012

    • Single centre case series

    • Reported as new technique

  • Phase II 2013

    • 5 sites, randomised closure, 90 patients

  • International phase III

    • 30 site in 2014, 450 patients

    • Reporting 2017


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