Surgical Site InfectionInSurgNCT04096885
The Inselspital Surgical Cohort Study
An observational study of Surgical Site Infection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Blood and urine samples, skin and stool swabs
- How many people
- 1,226 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Sep 2019to 28 Feb 2028
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing surgery at the Department of Visceral Surgery and Medicine, Inselspital, University Hospital Bern
Who may be able to join
- Patients undergoing surgery at the Department of Visceral Surgery and Medicine, Inselspital, University Hospital Bern
- Who gave General consent
- Study-specific written informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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
- Conditions
- Surgical Site Infection
- Being tested
- Blood and urine samples, skin and stool swabs
- Keywords
- cohort, visceral surgery, biobank
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| InSurg cohort | Patients who undergo elective or emergency surgery at the Department of Visceral Surgery and Medicine, Inselspital, Bern, who gave informed consent. Receives: Diagnostic Test: Blood and urine samples, skin and stool swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical site infection
Number of patients with surgical site infections 30 days postoperatively
Measured: 30 days
Secondary outcomes (6)
Stool - incidence of surgical site infections
Predictive value of preoperative stool sample for surgical site infections
Measured: 30 days
Urine - incidence of surgical site infections
Predictive value of preoperative urine sample for surgical site infections
Measured: 30 days
Blood - incidence of surgical site infections
Predictive value of pre and postoperative plasma metabolome for surgical site infections
Measured: 30 days
Somatic genomic in surgical site infections
Predictive value of somatic genomic variations for surgical site infections
Measured: 30 days
Informed Consent
Rate of inclusion for informed consenting
Measured: 3 years
Biobanking
Rate of inclusion for full biobanking
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start9 Sep 2019
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,226 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Beldi, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096885
- Sponsor's protocol ID
- 2019-00576
- Other IDs
- 2019
- Acronym
- InSurg
- Status last verified
- Apr 2026
- First submitted
- 30 Aug 2019
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Inselspital Surgical Cohort Study
- ClinicalTrials.gov ID
- NCT04096885
- Acronym / sponsor ID
- InSurg / 2019-00576
- Conditions
- Surgical Site Infection
- Keywords
- cohort, visceral surgery, biobank
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,226 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InSurg cohort | – | Diagnostic Test: Blood and urine samples, skin and stool swabsPatients who undergo elective or emergency surgery at the Department of Visceral Surgery and Medicine, Inselspital, Bern, who gave informed consent. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing surgery at the Department of Visceral Surgery and Medicine, Inselspital, University Hospital Bern
Key inclusion criteria (3 listed)
- Patients undergoing surgery at the Department of Visceral Surgery and Medicine, Inselspital, University Hospital Bern
- Who gave General consent
- Study-specific written informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and urine samples, skin and stool swabsBlood 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. | Diagnostic test | InSurg cohort |
Primary outcome
Incidence of surgical site infection
Time frame: 30 days
Number of patients with surgical site infections 30 days postoperatively
6 secondary outcomes
Stool - incidence of surgical site infections
Time frame: 30 days
Urine - incidence of surgical site infections
Time frame: 30 days
Blood - incidence of surgical site infections
Time frame: 30 days
Somatic genomic in surgical site infections
Time frame: 30 days
Informed Consent
Time frame: 3 years
Biobanking
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Beldi principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of surgical site infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.