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NCT Number: NCT04096885

The Inselspital Surgical Cohort Study

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.

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beldi Guido

Bern, 3010, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and urine samples, skin and stool swabs

Diagnostic Test

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.

Primary outcomes

  1. Incidence of surgical site infection

    Time frame: 30 days

    Number of patients with surgical site infections 30 days postoperatively

Secondary outcomes

  1. Stool - incidence of surgical site infections

    Time frame: 30 days

    Predictive value of preoperative stool sample for surgical site infections

  2. Urine - incidence of surgical site infections

    Time frame: 30 days

    Predictive value of preoperative urine sample for surgical site infections

  3. Blood - incidence of surgical site infections

    Time frame: 30 days

    Predictive value of pre and postoperative plasma metabolome for surgical site infections

  4. Somatic genomic in surgical site infections

    Time frame: 30 days

    Predictive value of somatic genomic variations for surgical site infections

  5. Informed Consent

    Time frame: 3 years

    Rate of inclusion for informed consenting

  6. Biobanking

    Time frame: 3 years

    Rate of inclusion for full biobanking

Other outcomes

  1. Intraoperative metabolomic Response to surgery

    Time frame: 8 weeks

    Metabolome will be extracted from the blood, skin, urine and stool samples analyzed using high resolution mass spectrometry. Metabolomic analysis will be obtained preoperatively in the outpatient setting (elective patients) or at the beginning (emergency patients) and end of the operation. Patterns of metabolites will be evaluated by untargeted analysis.

  2. Disease-free survival after surgery

    Time frame: 3 years

    Disease-free survival after surgery in years will be recorded in oncological patients, and interpreted according to surgical and anesthesia-specific responses after abdominal surgery, in terms of metabolomics analysis of the blood, skin, urine and stool samples, as described above.

  3. Recurrence-free survival after surgery

    Time frame: 3 years

    Recurrence-free survival after surgery in years will be recorded in oncological patients, and interpreted according to surgical and anesthesia-specific responses after abdominal surgery, in terms of metabolomics analysis of the blood, skin, urine and stool samples, as described above.

  4. Overall survival after surgery

    Time frame: 3 years

    Overall survival after surgery in years will be recorded in oncological patients, and interpreted according to surgical and anesthesia-specific responses after abdominal surgery, in terms of metabolomics analysis of the blood, skin, urine and stool samples, as described above.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Acronym: InSurg

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Sep 20, 2019
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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