GlobalSurg IIProtocol Summary

Determining the worldwide epidemiology of surgical site infections after gastriointestinal

surgery

www.globalsurg.org @GlobalSurg enquiry@globalsurg.org

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

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

Primary Aim• To determine worldwide surgical site infection rates

following gastrointestinal surgery

Secondary Aims1. 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

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

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

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

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 includedHernia repair with a bowel resection should be

included

Primary Outcome MeasurePrimary 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)

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

• 30-day postoperative mortality rate • Rate of antibiotic resistant SSI • Method of 30-day follow-up

Secondary Outcome Measures

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

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

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

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

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

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

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#/

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)

Our collaborators around the world!

More InformationWebsite: http://globalsurg.org/Email: enquiry@globalsurg.orgFacebook: 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