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The Inselspital Surgical Cohort Study (InSurg)

I

Insel Gruppe AG, University Hospital Bern

Status

Active, not recruiting

Conditions

Surgical Site Infection

Treatments

Diagnostic Test: Blood and urine samples, skin and stool swabs

Study type

Observational

Funder types

Other

Identifiers

NCT04096885
2019-00576

Details and patient eligibility

About

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.

Full 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

Enrollment

1,226 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,226 participants in 1 patient group

InSurg cohort
Description:
Patients who undergo elective or emergency surgery at the Department of Visceral Surgery and Medicine, Inselspital, Bern, who gave informed consent.
Treatment:
Diagnostic Test: Blood and urine samples, skin and stool swabs

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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