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The Inselspital Surgical Cohort Study

The Inselspital Surgical Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04096885
Acronym
InSurg
Enrollment
1226
Registered
2019-09-20
Start date
2019-09-09
Completion date
2028-02-28
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

Keywords

cohort, visceral surgery, biobank

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

Interventions

DIAGNOSTIC_TESTBlood and urine samples, skin and stool swabs

Blood samples will be collected before surgery, on the first postoperative day and after 3-8 weeks. Urine samples will be collected after surgery and after 3-8 weeks. Stool and skin swabs will be collected before surgery.

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of surgical site infection30 daysNumber of patients with surgical site infections 30 days postoperatively

Secondary

MeasureTime frameDescription
Stool - incidence of surgical site infections30 daysPredictive value of preoperative stool sample for surgical site infections
Urine - incidence of surgical site infections30 daysPredictive value of preoperative urine sample for surgical site infections
Blood - incidence of surgical site infections30 daysPredictive value of pre and postoperative plasma metabolome for surgical site infections
Somatic genomic in surgical site infections30 daysPredictive value of somatic genomic variations for surgical site infections
Informed Consent3 yearsRate of inclusion for informed consenting
Biobanking3 yearsRate of inclusion for full biobanking

Countries

Switzerland

Contacts

PRINCIPAL_INVESTIGATORGuido Beldi

Insel Gruppe AG, University Hospital Bern

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026