Determining the Worldwide Epidemiology of Surgical Site Infections After Gastrointestinal Surgery (GlobalSurg 2)
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|ClinicalTrials.gov Identifier: NCT02662231|
Recruitment Status : Unknown
Verified April 2016 by Ewen Harrison, University of Edinburgh.
Recruitment status was: Recruiting
First Posted : January 25, 2016
Last Update Posted : April 5, 2016
|Condition or disease||Intervention/treatment|
|Surgical Wound Infection||Procedure: Emergency, or elective gastrointestinal resection|
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 . 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|
|Estimated Enrollment :||10000 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Determining the Worldwide Epidemiology of Surgical Site Infections After Gastrointestinal Surgery|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||September 2016|
- Procedure: 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.
- 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.
- 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.
- 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.
- Rate of antibiotic-resistant surgical site infection [ Time Frame: Within 30 days of surgery ]Describing international variation, where available.
- 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)
- Proportion of patients treated in a hospital with microscopy, culture and sensitivity testing [ Time Frame: Within 30 days of surgery ]Patient-level, online questionnaire.
- 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)
- Complicated appendicitis rate [ Time Frame: Pre-, or intra-operatively ]Includes radiological or clinical perforation of the appendix, empyema or abscess formation, and fecal peritonitis.
- Laparoscopic cholecystectomy rate [ Time Frame: Intra-operatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662231
|Contact: Catherine Shaw||+44 131 242 firstname.lastname@example.org|
|Contact: James Glasbeyemail@example.com|
|University Hospitals Birmingham NHS Foundation Trust||Recruiting|
|Birmingham, United Kingdom, B15 2TH|
|Contact: Aneel Bhangu, MBBCh PhD (0)(+44)7789770619 firstname.lastname@example.org|
|Contact: James Glasbey, MBBCh BSc (0)(+44)7954344169 email@example.com|
|Royal Infirmary of Edinburgh||Recruiting|
|Edinburgh, United Kingdom, EH16 4SA|
|Contact: Ewen Harrison, FRCS PhD firstname.lastname@example.org|
|Contact: Stuart Fergusson, MBBCh MRCS email@example.com|
|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|