The Inselspital Surgical Cohort Study
- Conditions
- Surgical Site Infection
- Interventions
- Diagnostic Test: Blood and urine samples, skin and stool swabs
- Registration Number
- NCT04096885
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Brief Summary
Personalizing surgical care is of enormous clinical relevance, when considering the number of patients undergoing surgery in Switzerland every year. Currently, personalization is based on underlying or coexisting disease or alterations of laboratory values, but there is no accepted biological test available that may predict success or failure of surgery. Surgical site infections are the most common form of hospital-acquired infections. While the relevance of bacteria, antibiotics and intensive care support is well accepted, the impact of the individual host response remains poorly understood. The Investigators hypothesize that postoperative alterations of the metabolome allow identification of predictors of surgical complications in general, and surgical site infections in particular.
- Detailed Description
The investigators will conduct a prospective cohort study aiming to identify the metabolic and genetic signature that is associated with surgical site infections. Secondary aims and outcomes include the influence of metabolome on response to anesthetic drugs and acute and chronic pain, surgery- and anesthesia-factors related to short- and long-term oncological outcome, metabolic response effect on infectious complications and rejection after transplantation, bacteria-specific immune responses to major surgery after 2-4 weeks after surgery, metabolomics and macrobiotic markers for postoperative ileus or anastomotic leakage, and the effect of the presence of multidrug resistant bacteria on surgical outcome. All patients undergoing surgery in the investigators' clinic and who gave informed consent will be included. A blood sample will be taken before surgery, on the first postoperative day and after 3-8 weeks. A Urine sample will be taken after surgery and after 3-8 weeks. Sink and rectal swabs will be acquired before surgery. The samples will be stored in a Biobank. Additionally, all data routinely captured during the treatment of the patient from the different data collection systems in use in the investigators' hospital will be coded and centralized in a single, cohort database
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1226
- Patients undergoing surgery at the Department of Visceral Surgery and Medicine, Inselspital, University Hospital Bern
- Who gave General consent
- Study-specific written informed consent
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description InSurg cohort Blood and urine samples, skin and stool swabs Patients who undergo elective or emergency surgery at the Department of Visceral Surgery and Medicine, Inselspital, Bern, who gave informed consent.
- Primary Outcome Measures
Name Time Method Incidence of surgical site infection 30 days Number of patients with surgical site infections 30 days postoperatively
- Secondary Outcome Measures
Name Time Method Stool - incidence of surgical site infections 30 days Predictive value of preoperative stool sample for surgical site infections
Blood - incidence of surgical site infections 30 days Predictive value of pre and postoperative plasma metabolome for surgical site infections
Urine - incidence of surgical site infections 30 days Predictive value of preoperative urine sample for surgical site infections
Somatic genomic in surgical site infections 30 days Predictive value of somatic genomic variations for surgical site infections
Informed Consent 3 years Rate of inclusion for informed consenting
Biobanking 3 years Rate of inclusion for full biobanking
Trial Locations
- Locations (1)
Beldi Guido
🇨ðŸ‡Bern, Switzerland