NCT04096885

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,226

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Sep 2019Feb 2028

First Submitted

Initial submission to the registry

August 30, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

September 9, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

8.5 years

First QC Date

August 30, 2019

Last Update Submit

April 28, 2026

Conditions

Surgical Site Infection

Keywords

cohortvisceral surgerybiobank

Outcome Measures

Primary Outcomes (1)

  • Incidence of surgical site infection

    Number of patients with surgical site infections 30 days postoperatively

    30 days

Secondary Outcomes (6)

  • Stool - incidence of surgical site infections

    30 days

  • Urine - incidence of surgical site infections

    30 days

  • Blood - incidence of surgical site infections

    30 days

  • Somatic genomic in surgical site infections

    30 days

  • Informed Consent

    3 years

  • +1 more secondary outcomes

Other Outcomes (4)

  • Intraoperative metabolomic Response to surgery

    8 weeks

  • Disease-free survival after surgery

    3 years

  • Recurrence-free survival after surgery

    3 years

  • +1 more other outcomes

Study Arms (1)

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

Interventions

Blood and urine samples, skin and stool swabsDIAGNOSTIC_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.

InSurg cohort

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beldi Guido

Bern, 3010, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and stool samples pre- and post-operative for microbiota, genomic and metabolomic analysis

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Guido Beldi

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2019

First Posted

September 20, 2019

Study Start

September 9, 2019

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

February 28, 2028

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)