Talk given at the Dukes' Club AGM 2011

1. Trainee-led Surgical Research
Collaboratives
The West Midlands Research Collaborative
experience

2. The WMRC
• Background - why we formed
• Aims
• Why it works

3. Project
Methodology
& design Data
Collection
Team leading
& analysis
& working
Write papers
Patients
Enhance CV
Trainee
Publications
Multicentre
& Presentations Benefits of Trials
Research
Transferable Collaborative
skills Quality of
Research
More clinical
Region Better surgical trials
recruitment

4. Getting it off the Ground
• Enthusiastic Trainees
• Senior Support and guidance
• Consultant trainer support
• Trials Unit(s)
• National Support

5. Running the WMRC
• Regular meetings as a group
• Formation of a management committee
• Communication
• www.wmresearch.co.uk
• Forums
• E-mail

6. How to set up a collaborative
Formation of a committee
 Network Development
 Trial Development
 Overall organisation
Committee members:
 Chairperson
 Secretary
 Webmaster
 A junior surgical liaison
 Treasurer
 New study manager
 Chief Investigator of each study

7. Committee
Trial 1 Trial 2 Trial 3
Chief Investigator Chief Investigator Chief Investigator
Working Working Working
group group group
Local Local Local
investigators investigators investigators

8. How to set up a collaborative
Monthly group meeting
 Discuss existing trials
 New project presentations and discussions
 Educational talks
Cancer Intelligence Unit
Trials Unit
Clinical
 Journal club
 Individual trials meetings

9. Current Research Portfolio
3 RCTs  Cohort studies
ROSSINI  CANOES
 CHARMS
DREAMS
 ABPI
PHAROES
 Multicentre Audit
 Pancreatitis Study
 Qualitative research

10. Current Progress
• Around 45 trainees have GCP accreditation and are
randomising to ROSSINI
• Many more (junior) trainees are involved in our trials
• £232,000 NIHR RfPB grant for ROSSINI
• £131,000 BDRF grant for DREAMS
• £150,000 company sponsorship for PHAROES
• Presentations/Papers
• National Meetings

11. ROSSINI Trial
Reduction Of Surgical Site Infection
using a Novel Intervention
A multicentre, prospective randomised controlled trial of a
wound-edge protection device to reduce surgical site infection

12. ROSSINI Trial
• Primary Hypothesis:
Use of a wound-edge protection device in
adults undergoing laparotomy will result in a
reduced rate of surgical site infection (SSI) at
30 days.

13. Inclusion/Exclusion Criteria
• Inclusion criteria
– Any laparotomy
– Any Incision (eg midline, transverse, Kocher’s etc)
– Emergency or Elective
• Exclusion criteria
– Unable to consent
– Laparoscopic assisted cases
– Previous laparotomy within last 3 months

14. ROSSINI – Process
PATIENT CONSENT OPERATION FOLLOW UP A FOLLOW UP B
LISTED
Consent form Randomised in Day 5-7 wound Day 30-33 wound
Patient completed theatre (50:50) review review
Information
Sheet given CRF 1 CRF 2 CRF 3 CRF 4+5
EUROQOL EQ-5D
RESOURCE USE
Completed at end
CRF 6

15. ROSSINI sites (West Mids)
• University Hospital • University Hospital Coventry
Birmingham and Warwickshire
• Russells Hall Hospital • Royal Shrewsbury Hospital
• Walsall Manor Hospital • Princess Royal Hospital Telford
• City and Sandwell Hospitals • Hereford County Hospital
• Heartlands and Good Hope • Worcester Royal Hospital
Hospitals • George Elliot Hospital,
• Warwick Hospital Nuneaton
• University Hospital North
Staffordshire
• New Cross Hospital
Wolverhampton

16. ROSSINI sites (National)
• Royal Derby Hospital • St Marks, London
• Wrightington,Wigan and • Stepping Hill, Stockport
Leigh • Bolton
• Derriford Hospital, • The Christie, Manchester
Plymouth
• Wrexham
• Hope Hospital, Salford
• Glan Clwyd
• Royal Devon and Exeter
Hospital • Manchester Royal Infirmary
• Medway • Yeovil
• Maidstone + Tunbridge
Wells
• The Homerton, London

17. ROSSINI recruitment at 31st March 2011
900 20
800 18
16
700
Patients recruited 14
600
Sites open
12
500
10
400
8
300
6
200
4
100 2
0 0
Mar-10 May-10 Jul-10 Sep-10 Nov-10 Jan-11 Mar-11 May-11 Jul-11 Sep-11 Nov-11 Jan-12 Mar-12
Apr-10 Jun-10 Aug-10 Oct-10 Dec-10 Feb-11 Apr-11 Jun-11 Aug-11 Oct-11 Dec-11 Feb-12
Predicted sites open 0 1 1 2 3 4 5 6 7 9 10 12 13 15 16 18 18 18 19 19 19 19 19 19 19
Actual sites open 1 1 1 2 3 5 9 12 12 13 15 17
Actual sites recruiting 1 1 1 2 3 4 7 8 9 10 13 13
Minimum cumulative recruitment
0 3 6 11 19 30 44 60 78 102 129 161 195 235 277 324 371 418 468 517 567 616 665 715 764
(750)
Actual cumulative recruitment 12 17 21 26 44 51 69 82 109 117 157 201 261

19. Spreading the word
• RCS support
• SARS / ASGBI support
• Presentations at ASIT, ASGBI, SARS, ACPGBI
• Networking with other groups of trainees
• London / Trent / Southampton / Bristol / Leeds

20. Future Development
LSRG
SPARCS
Leeds group
National cardiothoracic research collaborative

21. Contact us
WMRC Website:
http://www.wmresearch.org.uk
E mail committee members:
committee@wmresearch.co.uk

22. Dexamethasone Reduces Emesis
After Major Gastrointestinal Surgery

23. TRIAL DESIGN AND PATHWAY
• Phase
3, prospective, double-
blind, multicentre, RCT.
• Consecutive
unobstructed patients
undergoing colorectal
surgery (inside and
outside of ERAS).
• Randomised 1:1

24. WHAT YOU NEED TO DO TO
COLLABORATE
• Further information at: wmresearch.org.uk
• E-mail: dreams@wmresearch.co.uk