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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2016 by Ewen Harrison, University of Edinburgh
Sponsor:
Collaborator:
University of Birmingham
Information provided by (Responsible Party):
Ewen Harrison, University of Edinburgh
ClinicalTrials.gov Identifier:
NCT02662231
First received: January 5, 2016
Last updated: April 1, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Surgical Wound Infection Procedure: Emergency, or elective gastrointestinal resection

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Determining the Worldwide Epidemiology of Surgical Site Infections After Gastrointestinal Surgery

Further study details as provided by Ewen Harrison, University of Edinburgh:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 10000
Study Start Date: January 2016
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients undergoing emergency, or elective gastrointestinal resection, cholecystectomy and appendectomy.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02662231

Contacts
Contact: Catherine Shaw +44 131 242 3631 catherine.shaw@ed.ac.uk
Contact: James Glasbey +447954344169 jamesglasbey@gmail.com

Locations
United Kingdom
University Hospitals Birmingham NHS Foundation Trust Recruiting
Birmingham, United Kingdom, B15 2TH
Contact: Aneel Bhangu, MBBCh PhD    (0)(+44)7789770619    aneel.bhangu@gmail.com   
Contact: James Glasbey, MBBCh BSc    (0)(+44)7954344169    jamesglasbey@gmail.com   
Royal Infirmary of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Ewen Harrison, FRCS PhD       ewen.harrison@gmail.com   
Contact: Stuart Fergusson, MBBCh MRCS       stuart.fergusson@ed.ac.uk   
Sponsors and Collaborators
University of Edinburgh
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
  More Information

Additional Information:
Publications:

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
GlobalSurg-II Study Protocol: available in multiple languages
Training Module  This link exits the ClinicalTrials.gov site
Mandatory surgical site infection training module

Responsible Party: Ewen Harrison, Senior Lecturer iGeneral Surgery, University of Edinburgh
ClinicalTrials.gov Identifier: NCT02662231     History of Changes
Other Study ID Numbers: GlobalSurg 2 Edinburgh
Study First Received: January 5, 2016
Last Updated: April 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be made available upon request, to enable patient level meta-analysis

Keywords provided by Ewen Harrison, University of Edinburgh:
Surgical Site Infection
General Surgery
Laparotomy
Outcome and Process Assessment (Health Care)
Developing Countries
International Cooperation
Specialties, Surgical
Developed Countries
Quality of Health Care

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wound Infection
Surgical Wound Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 21, 2017