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GlobalSurg II - Protocol Summary

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The summary protocol of the GlobalSurg II study.

GlobalSurg II aims to determine worldwide surgical site infection (SSI) rates following gastrointestinal surgery. The primary end point for the study is 30 day surgical site infection rate.

1. Any hospital in the world performing emergency or elective gastrointestinal surgery is eligible to enter

2. This is a low burden project; Only 30 data points per patient are required

3. Data collection: 4th January 2016 to 31st July 2016 (with follow-up of the last period until 30th August)

4. PubMed citable authorship attributed to all collaborators

For full details please visit: www.globalsurg.org

Published in: Healthcare
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GlobalSurg II - Protocol Summary

  1. 1. GlobalSurg II Protocol Summary Determining the worldwide epidemiology of surgical site infections after gastriointestinal surgery www.globalsurg.org @GlobalSurg enquiry@globalsurg.org
  2. 2. About GlobalSurg • The GlobalSurg Collaborative is a network of over 3000 clinicians across more than 70 countries around the world • Run by the SURG Foundation charity, GlobalSurg projects are designed to promote international surgical networks • The first GlobalSurg study included prospective outcomes data on over 10,000 patients undergoing emergency abdominal surgery • Over 1500 collaborators participated in the GlobalSurg I study • All collaborators are PubMed citable on all resulting journal publications, which are published under the GlobalSurg group name
  3. 3. Background • Surgical site infection (SSI) is the most common complication following surgery • SSI can affect up to 25% of patients after a midline laparotomy • SSI influences patient morbidity, mortality, and the cost of care • The first GlobalSurg study identified that the incidence of SSI more than doubled from high (7.4%) to low (20%) human development index (HDI) countries.The reasons for this are not fully understood • With the prevalence of antibiotic resistance rising and many hospitals not collecting data on SSI rates, investigating the causes, diagnosis and treatment is now a global priority in surgery
  4. 4. Primary Aim • To determine worldwide surgical site infection rates following gastrointestinal surgery
  5. 5. Secondary Aims 1. Determine access to routine microbiological tests 2. Determine the rates of antibiotic resistant SSI 3. Assess how 30-day follow-up is completed 4. To assess the impact of pre-hospital delays
  6. 6. Study Methods • Individual teams with up to three people, collecting data for 2 weeks (+ 30 day follow up) during a selected time period • Time period for participating in the study: Any 2-week period from 4 January 2016 - 31 July 2016 Multiple teams covering different time periods from the same hospital/centre are encouraged
  7. 7. Definitions • Gastrointestinal resection • Complete transection and removal of a segment of the oesophagus, stomach, small bowel, colon or rectum • Emergency procedure • An unplanned, non-elective operations and include reoperations after previous procedures
  8. 8. Inclusion Criteria Inclusion Criteria • Any hospital in the world performing gastrointestinal surgery • All consecutive patients undergoing elective or emergency gastrointestinal resection, cholecystectomy or appendicetomy • Any operative approach (open, laparoscopic, laparoscopic-assisted, laparoscopic-converted and robotic) • Patients of any age Each individual patient should only be included in the study once. Patients returning to theatre due to complications following earlier surgery can be included, as long as their original index procedure has not already been included
  9. 9. Exclusion Criteria Exclusion Criteria •Operations with primary indication that is vascular, gynaecological, urological (including ileal conduit) or transplant •Caesarean section, Whipples procedure, Simple hernia repair Primary trauma indication should be included Hernia repair with a bowel resection should be included
  10. 10. Primary Outcome Measure Primary outcome measure: Incisional SSI (superficial or deep wound) within 30 days of surgery To diagnose a surgical site infection the patient must have at least one of: • Purulent drainage from incision • Abscess within the wound (detected clinically or radiologically) Or one of the following combinations: • Pain or tenderness or localised swelling or redness or heat or fever • AND the incision is opened deliberately or spontaneously opens (dehisces)
  11. 11. How to measure SSI? • Measured at 30-days after surgery either in person or by computer record/chart review • If 30-day follow up is not possible, SSI will be measured at the point of discharge We strongly encourage teams to assess patients at 30-days (in-person or via telephone), as this is the only way to audit practice properly
  12. 12. • 30-day postoperative mortality rate • Rate of antibiotic resistant SSI • Method of 30-day follow-up Secondary Outcome Measures
  13. 13. Study Approvals • Local investigators must gain approval from one of the following: • Clinical Audit department • Research department / Institutional Review Boards • If these are not present, email or written permission should be gained from the next best available source • Local investigators will be solely responsible for ensuring they have followed the correct mechanisms for this and will be asked to confirm local approval when their data is submitted
  14. 14. Data Collection • Data can be initially collected on paper forms, which can be downloaded from here (http://globalsurg.org/globalsurg-2-protocol/) • All data MUST be uploaded on to the REDCap webpage • REDCap is a secure online webpage, provided by the University of Edinburgh in the UK (http://project-redcap.org) • REDCap is used around the world to securely gather research data
  15. 15. Getting a REDCap login • REDCap logins for submitting data will be given out by the steering committee via an online form • Please only fill the request form out once • REDCap logins are not issued immediately, as they require approval from a system administrator. Please allow 5 working days for processing this • If you have not received your login for REDCap, please contact your country lead to ask about this
  16. 16. Primary method • Daily review of theatre logbooks or operating lists, from all appropriate operating rooms Supplementary methods • Daily review of handover sheets / emergency admission and ward patient lists Methods to identify eligible patients to include
  17. 17. Patient Follow up • Investigators are encouraged to actively monitor patients to identify SSI to 30 days from the operation • Investigators should be proactive in identifying SSI using the methods described below: Daily review of patient and their notes during admission Reviewing the patient status in outpatient clinic Review patient via telephone at 30 days Checking hospital records (electronic or paper) and discharge summaries Check handover lists for re-attendances or re- admissions Checking for Emergency Department re- attendances
  18. 18. Analysis of Results • Outcomes will be reported stratified by the human development index (HDI). • Data will not be analysed or reported for an individual surgeon, hospital or country. • A secondary aim is to determine the rate of antibiotic resistant SSI, creating a roadmap for causative organisms around the world
  19. 19. Registration and Training for Collaborators • Register your interest at: http://globalsurg.org/register/ • Full protocol available to download at: http://globalsurg.org/globalsurg-2-protocol/ We have developed a short training module to help you diagnose surgical site infection It is mandatory to complete this module prior to starting data collection The required pass mark is 100% The SSI module is available online here: http://globalsurg.org/ssi/index.html#/
  20. 20. Our collaborators “SSI are a major problem in surgery. I have been researching on surgical site events during the last years and there is crying need of robust data! Globalsurg II is likely to provide high quality evidence. Count on me” – Gianluca Pellino (Italy collaborator) “Look forward to become part of the global surgery family” – Knut Magne (Norway collaborator) “Surgical site infection represents a big issue in our hospital and we try to know the exact incidence and the impact on our results but unfortunately we couldn't, so I'm encouraged to share in a big study that well help all” – Mazin Abdulla (Iraq collaborator) “I want to contribute and learn a lot from this project that encourages research in surgery in my country” – Benjamín Jesús Ramos Rojas (Peru collaborator) “I just want to say that it's a great opportunity, and i've been preparing myself for 5 years for it .. and since it's my first time to take part in such a huge study” – Egypt collaborator “The research is a great work and I am happy to be part of it.” – Samson Olori (Nigeria collaborator)
  21. 21. Our collaborators around the world!
  22. 22. More Information Website: http://globalsurg.org/ Email: enquiry@globalsurg.org Facebook: https://www.facebook.com/GlobalSurg Twitter: https://twitter.com/GlobalSurg GlobalSurg is run by the SURG Foundation charity. Please donate to support us: https://www.givey.com/surg_foundation

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