Clinical trial NCT02662231: Determining the Worldwide Epidemiology of Surgical Site Infections After Gastrointestinal Surgery
Official title: Determining the Worldwide Epidemiology of Surgical Site Infections After Gastrointestinal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Wound Infection
Keywords: Surgical Site Infection
General Surgery
Laparotomy
Outcome and Process Assessment (Health Care)
Developing Countries
International Cooperation
Specialties, Surgical
Developed Countries
Quality of Health Care
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: University of Birmingham
First posted: 2016-01-25
Enrollment: 12539
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing emergency, or elective gastrointestinal resection, cholecystectomy and appendectomy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Superficial incisional surgical site infection (SSI)
timeFrame: Within 30 days of surgery
Secondary outcomes:
measure: Postoperative mortality rate (POMR)
timeFrame: Within 30 days of surgery
measure: Postoperative re-intervention rate
timeFrame: Within 30 days of surgery
measure: Rate of antibiotic-resistant surgical site infection
timeFrame: Within 30 days of surgery
measure: Organism causing surgical site infection
timeFrame: Within 30 days of surgery
measure: Proportion of patients treated in a hospital with microscopy, culture and sensitivity testing
timeFrame: Within 30 days of surgery
Other outcomes:
measure: Follow up method for detecting surgical site infection
timeFrame: Within 30 days of surgery
measure: Complicated appendicitis rate
timeFrame: Pre-, or intra-operatively
measure: Laparoscopic cholecystectomy rate
timeFrame: Intra-operatively
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
affiliation: University of Birmingham
name: Aneel Bhangu
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Edinburgh
name: Ewen M Harrison
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Free London NHS Foundation Trust
name: Edward Fitzgerald
role: PRINCIPAL_INVESTIGATOR
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