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Surgical Research Networks

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

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  1. Surgical Research Networks December 2013

  2. Benefiting from Trials • Improving care for surgical patients • Delivering advances in medicine • Disseminating best practice

  3. 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%

  4. 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

  5. Open studies on the CRN portfolio: 2012-13

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

  7. Building Networks Trainee Collaboratives:Experience with Surgical Trials 

  8. Background • WMRC • Gen Surgery-Trainee led research group • Clinical research alongside training

  9. 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

  10. 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

  11. Published in the BMJ

  12. 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

  13. General Surgical Research Collaboratives Newcastle Surgical Research Collaborative Scottish Surgical Registrars Research Group

  14. AIM • Aim: a national (international), multicentre, audit of appendicectomy • Primary outcome: negative appendicectomy rate • Secondary outcomes: laparoscopy, adverse events • Inclusion: appendicectomy, all ages

  15. Recruitment • 95 centres • 3326 patients • 89 UK centres • 6 international centres

  16. Driving trials recruitment

  17. Building the Infrastructure • Open new trials • Engage clinicians • Provide expertise

  18. 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

  19. A new era • Specialist trials unit support • Specialty leads • Developing study groups • Developing collaboration • Trainee Networks • Nationwide • Multidisciplinary

  20. 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

  21. ROCSS: Reinforcement of Closure of Stoma Site

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

  23. 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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