The Inselspital Surgical Cohort Study (InSurg)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Surgical Site Infection
• Intervention / Treatment: Diagnostic test: Blood and urine samples, skin and stool swabs

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

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Beldi Guido

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery at the Department of Visceral Surgery and Medicine, Inselspital, University Hospital Bern

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
InSurg cohort; Patients who undergo elective or emergency surgery at the Department of Visceral Surgery and Medicine, Inselspital, Bern, who gave informed consent.	Diagnostic test: Blood 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of surgical site infection	Number of patients with surgical site infections 30 days postoperatively	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool - incidence of surgical site infections	Predictive value of preoperative stool sample for surgical site infections	30 days
Urine - incidence of surgical site infections	Predictive value of preoperative urine sample for surgical site infections	30 days
Blood - incidence of surgical site infections	Predictive value of pre and postoperative plasma metabolome for surgical site infections	30 days
Somatic genomic in surgical site infections	Predictive value of somatic genomic variations for surgical site infections	30 days
Informed Consent	Rate of inclusion for informed consenting	3 years
Biobanking	Rate of inclusion for full biobanking	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative metabolomic Response to surgery	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.	8 weeks
Disease-free survival after surgery	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 years
Recurrence-free survival after surgery	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.	3 years
Overall survival after surgery	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.	3 years

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Guido Beldi, University Hospital Inselspital, Berne

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2019
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (ACTUAL): September 20, 2019

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: biobank; cohort; visceral surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection
• Other Study ID Numbers: 2019-00576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No