Determining the Worldwide Epidemiology of Surgical Site Infections After Gastrointestinal Surgery

NCT ID: NCT02662231

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12539 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2016-09-30

Brief Summary

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.

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.

Conditions

Surgical Wound Infection

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Interventions

Emergency, or elective gastrointestinal resection

Gastrointestinal resection is defined as complete transection and removal of a segment of the oesophagus, stomach, small bowel, colon or rectum, including cholecystectomy, and appendicectomy.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Birmingham

OTHER

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aneel Bhangu

Role: PRINCIPAL_INVESTIGATOR

University of Birmingham

Ewen M Harrison

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Edward Fitzgerald

Role: PRINCIPAL_INVESTIGATOR

Royal Free London NHS Foundation Trust

Locations

University Hospitals Birmingham NHS Foundation Trust

Birmingham, , United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Countries

United Kingdom

References

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Study Documents

Document Type: Study Protocol

GlobalSurg-II Study Protocol: available in multiple languages

View Document

Related Links

http://globalsurg.org/projects/globalsurg-2/

GlobalSurg-II Project Hub

Other Identifiers

GlobalSurg 2 Edinburgh

Identifier Type: -

Identifier Source: org_study_id