Determining the Worldwide Epidemiology of Surgical Site Infections After Gastrointestinal Surgery (NCT02662231) | Clinical Trial Compass
CompletedNot Applicable
Determining the Worldwide Epidemiology of Surgical Site Infections After Gastrointestinal Surgery
United Kingdom12,539 participantsStarted 2016-01-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Superficial incisional surgical site infection (SSI)