Determining the Worldwide Epidemiology of Surgical Site Infections After Gastrointestinal Surgery (GlobalSurg 2)

May 20, 2024 updated by: University of Edinburgh
Surgical site infection (SSI) is the most common complication following major gastrointestinal surgery, affecting between 25-40% of patients. The rate of SSI doubles from low-income to high-income settings, persisting after risk adjustment. Investigating the diagnosis and treatment of SSIs remains a largely unaddressed global health priority. The impact of antibiotic resistant organisms and the effectiveness of antibiotic prophylaxis are unknown. This study aims to determine SSI rates following gastrointestinal surgery across worldwide hospital settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The burden of surgically disease in low and middle-income countries (LMICs) is growing. Specific programmes have aimed to raise the profile of safe surgery and anaesthesia on the global health agenda. The Lancet Commission on Global Surgery have outlined six core indicators for the assessment of global surgical systems, including the postoperative mortality rate (POMR). Although mortality is the most extreme outcome of surgery, it only affects 1-4% of all patients. For major gastrointestinal surgery, efforts to quantify POMR alone neglect the associated morbidity, which is likely to affect a far greater proportion of patients [1]. More relevant markers of postoperative outcome are needed for the majority of patients, who will survive surgery.

Surgical site infection (SSI) is the most common complication following major gastrointestinal surgery, affecting between 25-40% of patients after midline laparotomy in high-income settings, and affects both adults and children. The effects of SSI can be life threatening. They are related to one-third of postoperative deaths and accounts for 8% of all deaths caused by a nosocomial infection. Furthermore, SSIs cause pain and discomfort, increasing the time taken to return home thus further amplifying the patient's potential nosocomial infection risk. This has an important economic impact. In the UK, hospital length of stay is doubled, with an attributable cost of £30 million per year.

The 2014 prospective, observational cohort study (GlobalSurg-1) included 10,475 patients from 58 countries. It showed that the incidence of SSI more than doubled from high (7.4%), to middle (14.4%), to low (20.0%) income countries. This persisted after multivariable risk adjustment for patient and hospital confounders (middle income: odds ratio 1.96 [1.63-2.32] and low income: 2.06 [1.67-2.57]). In the most contaminated and dirty operations, one in three patients from LMICs suffered an SSI. Dirty surgery doubled in low-income countries (29.7% versus 16.6% in high-income settings), which was in turn associated with doubling of SSI (34.5% low-income versus 15.4% high-income). However, SSI was assessed as a secondary outcome measure as part of that study, lacking validity and requiring external validation.

Antibiotic resistant organisms are now prevalent worldwide and a focus of interest for policy leaders and global health advocates. Some hospitals have no information on the rate of antibiotic resistant SSIs. For those patients who contract infections caused by resistant organisms, they are posed with a higher risk of mortality, morbidity and require more healthcare resources. Currently no data exists to describe the international epidemiology of SSIs, their causative organisms and drug-resistance. Therefore, investigating the diagnosis and treatment of SSIs is an urgent global health priority.

The primary aim of this study is to determine SSI rates across low, middle and high Human Development Index (HDI) countries. The secondary aims include describing organisms causing SSI rates, use of microbiologic tests, and rate of antibiotic resistant SSI. The impact of the method of 30-day follow-up on these outcomes will also be analysed. Other aims include describing the burden of surgical disease using 30-day mortality rates, perforated appendicitis rates and laparoscopic cholecystectomy rates.

Study Type

Observational

Enrollment (Actual)

12539

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Consecutive patients undergoing emergency, or elective gastrointestinal resection, cholecystectomy and appendectomy.

Description

Centre Inclusion Criteria:

  • Any surgical unit worldwide is eligible to enter
  • All participating centres will be required to register their details, complete an online training module, and complete a pilot audit prior to commencing
  • Centres must ensure that they can include consecutive patients and provide at least 95% data completeness
  • There is no minimum number of patients per centre, as long as the patient(s) included are consecutive

Inclusion criteria:

  • Patients of all ages (adult and paediatric)
  • Consecutive patients during a chosen 14-day study period
  • Undergoing emergency or elective gastrointestinal resection, cholecystectomy and appendectomy.
  • Includes open, laparoscopic, laparoscopic converted and robotic cases
  • Primary indication of trauma should be included
  • Hernia repair with bowel resection should be included

Exclusion criteria:

  • Operations with a primary indication that is vascular, gynaecological, urological (including ileal conduit) or transplant
  • Caesarean sections
  • Whipples procedure
  • Simple hernia repair

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superficial incisional surgical site infection (SSI)
Time Frame: Within 30 days of surgery
This measure adapts the definitions within the 2008 Centre for Disease Control definitions of SSI.
Within 30 days of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative mortality rate (POMR)
Time Frame: Within 30 days of surgery
Death any time after skin incision until the 30th day after surgery. If the patient is discharged alive but not seen again by day 30, this is equivalent to the in-patient mortality rate.
Within 30 days of surgery
Postoperative re-intervention rate
Time Frame: Within 30 days of surgery
Operative, radiological or endoscopic re-intervention any time after skin incision until the 30th day after surgery. If the patient is discharged alive but not seen again by day 30, this is equivalent to the inpatient re-intervention rate.
Within 30 days of surgery
Rate of antibiotic-resistant surgical site infection
Time Frame: Within 30 days of surgery
Describing international variation, where available.
Within 30 days of surgery
Organism causing surgical site infection
Time Frame: Within 30 days of surgery
Patient-level, online questionnaire. Organisms identified upon microscopy and culture. Grouped by recognised causative bacteria in superficial surgical site infection (i.e. Staphylococcus Aureus, Coliform, Anaerobe, Other)
Within 30 days of surgery
Proportion of patients treated in a hospital with microscopy, culture and sensitivity testing
Time Frame: Within 30 days of surgery
Patient-level, online questionnaire.
Within 30 days of surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow up method for detecting surgical site infection
Time Frame: Within 30 days of surgery
Assessing method used to detect SSI at thirty day review (i.e. still an inpatient, clinic review, telephone review, community/home review, discharged before 30 days and not contacted again)
Within 30 days of surgery
Complicated appendicitis rate
Time Frame: Pre-, or intra-operatively
Includes radiological or clinical perforation of the appendix, empyema or abscess formation, and fecal peritonitis.
Pre-, or intra-operatively
Laparoscopic cholecystectomy rate
Time Frame: Intra-operatively
Intra-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

University of Birmingham

Investigators

  • Principal Investigator: Aneel Bhangu, University of Birmingham
  • Principal Investigator: Ewen M Harrison, University of Edinburgh
  • Principal Investigator: Edward Fitzgerald, Royal Free London NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

July 31, 2016

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 19, 2016

First Posted (Estimated)

January 25, 2016

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GlobalSurg 2 Edinburgh

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be made available upon request, to enable patient level meta-analysis

Study Data/Documents

  1. Study Protocol
    Information comments: GlobalSurg-II Study Protocol: available in multiple languages

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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