Clinical trial NCT04096885: The Inselspital Surgical Cohort Study
Official title: The Inselspital Surgical Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Surgical Site Infection
Keywords: cohort
visceral surgery
biobank
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 1226
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery at the Department of Visceral Surgery and Medicine, Inselspital, 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

Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery at the Department of Visceral Surgery and Medicine, Inselspital, University Hospital Bern
* Who gave General consent
* Study-specific written informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of surgical site infection
timeFrame: 30 days
Secondary outcomes:
measure: Stool - incidence of surgical site infections
timeFrame: 30 days
measure: Urine - incidence of surgical site infections
timeFrame: 30 days
measure: Blood - incidence of surgical site infections
timeFrame: 30 days
measure: Somatic genomic in surgical site infections
timeFrame: 30 days
measure: Informed Consent
timeFrame: 3 years
measure: Biobanking
timeFrame: 3 years
Other outcomes:
measure: Intraoperative metabolomic Response to surgery
timeFrame: 8 weeks
measure: Disease-free survival after surgery
timeFrame: 3 years
measure: Recurrence-free survival after surgery
timeFrame: 3 years
measure: Overall survival after surgery
timeFrame: 3 years
Locations:
city: Bern
country: Switzerland
facility: Beldi Guido
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Guido Beldi
role: PRINCIPAL_INVESTIGATOR
References: