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| Name | Class |
|---|---|
| University of Birmingham | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergency, or elective gastrointestinal resection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Superficial incisional surgical site infection (SSI) | This measure adapts the definitions within the 2008 Centre for Disease Control definitions of SSI. | Within 30 days of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative mortality rate (POMR) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Follow up method for detecting surgical site infection | 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 |
Centre Inclusion Criteria:
Inclusion criteria:
Exclusion criteria:
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Consecutive patients undergoing emergency, or elective gastrointestinal resection, cholecystectomy and appendectomy.
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| Name | Affiliation | Role |
|---|---|---|
| Aneel Bhangu | University of Birmingham | Principal Investigator |
| Ewen M Harrison | University of Edinburgh | Principal Investigator |
| Edward Fitzgerald | Royal Free London NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B15 2TH | United Kingdom | |||
| Royal Infirmary of Edinburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22998715 | Background | Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9. | |
| 25354824 |
| Label | URL |
|---|---|
| GlobalSurg-II Project Hub | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
Individual participant data will be made available upon request, to enable patient level meta-analysis
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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Not provided
| ID | Term |
|---|---|
| D004636 | Emergency Service, Hospital |
| ID | Term |
|---|---|
| D006748 | Hospital Departments |
| D006739 | Hospital Administration |
| D058016 | Health Facility Administration |
| D006268 | Health Facilities |
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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 | Describing international variation, where available. | Within 30 days of surgery |
| Organism causing surgical site infection | 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 | Patient-level, online questionnaire. | Within 30 days of surgery |
Includes radiological or clinical perforation of the appendix, empyema or abscess formation, and fecal peritonitis. |
| Pre-, or intra-operatively |
| Laparoscopic cholecystectomy rate | Intra-operatively |
| Edinburgh |
| EH16 4SA |
| United Kingdom |
| Background |
| Bhangu A, Fitzgerald JE, Fergusson S, Khatri C, Holmer H, Soreide K, Harrison EM. Determining universal processes related to best outcome in emergency abdominal surgery: a multicentre, international, prospective cohort study. BMJ Open. 2014 Oct 29;4(10):e006239. doi: 10.1136/bmjopen-2014-006239. |
| 23903454 | Background | Pinkney TD, Calvert M, Bartlett DC, Gheorghe A, Redman V, Dowswell G, Hawkins W, Mak T, Youssef H, Richardson C, Hornby S, Magill L, Haslop R, Wilson S, Morton D; West Midlands Research Collaborative; ROSSINI Trial Investigators. Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial). BMJ. 2013 Jul 31;347:f4305. doi: 10.1136/bmj.f4305. |
| 15367425 | Background | Wilson AP, Gibbons C, Reeves BC, Hodgson B, Liu M, Plummer D, Krukowski ZH, Bruce J, Wilson J, Pearson A. Surgical wound infection as a performance indicator: agreement of common definitions of wound infection in 4773 patients. BMJ. 2004 Sep 25;329(7468):720. doi: 10.1136/bmj.38232.646227.DE. Epub 2004 Sep 14. |
| 18538699 | Background | Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available. |
| 24252483 | Background | Laxminarayan R, Duse A, Wattal C, Zaidi AK, Wertheim HF, Sumpradit N, Vlieghe E, Hara GL, Gould IM, Goossens H, Greko C, So AD, Bigdeli M, Tomson G, Woodhouse W, Ombaka E, Peralta AQ, Qamar FN, Mir F, Kariuki S, Bhutta ZA, Coates A, Bergstrom R, Wright GD, Brown ED, Cars O. Antibiotic resistance-the need for global solutions. Lancet Infect Dis. 2013 Dec;13(12):1057-98. doi: 10.1016/S1473-3099(13)70318-9. Epub 2013 Nov 17. |
| 24252477 | Background | Earnshaw S, Mendez A, Monnet DL, Hicks L, Cruickshank M, Weekes L, Njoo H, Ross S. Global collaboration to encourage prudent antibiotic use. Lancet Infect Dis. 2013 Dec;13(12):1003-4. doi: 10.1016/S1473-3099(13)70315-3. Epub 2013 Nov 17. No abstract available. |
| 19446918 | Background | Tanner J, Khan D, Aplin C, Ball J, Thomas M, Bankart J. Post-discharge surveillance to identify colorectal surgical site infection rates and related costs. J Hosp Infect. 2009 Jul;72(3):243-50. doi: 10.1016/j.jhin.2009.03.021. Epub 2009 May 15. |
| 11247680 | Background | Plowman R, Graves N, Griffin MA, Roberts JA, Swan AV, Cookson B, Taylor L. The rate and cost of hospital-acquired infections occurring in patients admitted to selected specialties of a district general hospital in England and the national burden imposed. J Hosp Infect. 2001 Mar;47(3):198-209. doi: 10.1053/jhin.2000.0881. |
| 15866006 | Background | Coello R, Charlett A, Wilson J, Ward V, Pearson A, Borriello P. Adverse impact of surgical site infections in English hospitals. J Hosp Infect. 2005 Jun;60(2):93-103. doi: 10.1016/j.jhin.2004.10.019. |
| 18550218 | Background | Smyth ET, McIlvenny G, Enstone JE, Emmerson AM, Humphreys H, Fitzpatrick F, Davies E, Newcombe RG, Spencer RC; Hospital Infection Society Prevalence Survey Steering Group. Four country healthcare associated infection prevalence survey 2006: overview of the results. J Hosp Infect. 2008 Jul;69(3):230-48. doi: 10.1016/j.jhin.2008.04.020. Epub 2008 Jun 11. |
| 25934019 | Background | Meara JG, Greenberg SL. The Lancet Commission on Global Surgery Global surgery 2030: Evidence and solutions for achieving health, welfare and economic development. Surgery. 2015 May;157(5):834-5. doi: 10.1016/j.surg.2015.02.009. No abstract available. |
| 36626409 | Derived | NIHR Global Health Research Unit on Global Surgery, GlobalSurg Collaborative. Use of Telemedicine for Postdischarge Assessment of the Surgical Wound: International Cohort Study, and Systematic Review With Meta-analysis. Ann Surg. 2023 Jun 1;277(6):e1331-e1347. doi: 10.1097/SLA.0000000000005506. Epub 2022 Jun 27. |
| 29452941 | Derived | GlobalSurg Collaborative. Surgical site infection after gastrointestinal surgery in high-income, middle-income, and low-income countries: a prospective, international, multicentre cohort study. Lancet Infect Dis. 2018 May;18(5):516-525. doi: 10.1016/S1473-3099(18)30101-4. Epub 2018 Feb 13. |
| 28733294 | Derived | GlobalSurg Collaborative. Determining the worldwide epidemiology of surgical site infections after gastrointestinal resection surgery: protocol for a multicentre, international, prospective cohort study (GlobalSurg 2). BMJ Open. 2017 Jul 21;7(7):e012150. doi: 10.1136/bmjopen-2016-012150. |
GlobalSurg-II Study Protocol: available in multiple languages |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D005159 | Health Care Facilities Workforce and Services |
| D004632 | Emergency Medical Services |
| D006296 | Health Services |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |