Clinical trial NCT03554148: Bacteria and Intestinal Translocation in Surgery (Bandit)
Official title: Assessment of Bacterial Translocation on the Incidence of Surgical Site Infection in Abdominal Surgery: Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgical Site Infection
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing elective visceral surgery. Mostly for oncological indications.

Brief summary: Patients undergoing elective abdominal surgery will be included prospectively. Informed consent will be obtained. Preoperatively baseline health data is collected and a skin swab and rectal swab for baseline skin and gut microbiota is taken. During the surgery additional clinical data and additional samples will be obtained. Additional samples include: rectal swab, biopsies of the resected specimen (lymph node, peritoneum, intestinal content, mucosa), venous blood sample (7.5ml) at the end of the operation, liver biopsy and skin biopsy. Postoperative health data is recorded. If a surgical site infection occurs a swab is taken too. With 16 sRNA (small ribonucleic acid) based sequencing the investigators will quantify the abundance of the different bacterial species in all samples. Primary outcome will be to assess a difference of 16sRNA signal in the liver and lymph node biopsies between patients with and patients without surgical site infection. Secondary outcomes include variables predicting the occurence of surgical site infections and a model describing the way bacteria may take to cause wound infection.


Eligibility criteria: Inclusion Criteria:

* Informed Consent
* All Ages
* All Gender
* Elective Abdominal Surgery
* Age \> 18
* All approached (laparoscopic, open)
* All ethnic and sociodemographic backgrounds
* Sufficient knowledge of the study language (German)

Exclusion Criteria:

* pregnant or lactating women
* no operation performed (i.e. only planned)
* insufficient knowledge of project language (German)
* lack of informed consent
* known colonization with multi-resistant bacteria (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or extended spectrum betalactamase (ESBL))
* known cirrhotic liver disease

Primary outcomes:
measure: Detection of bacterial DNA in liver biopsy
timeFrame: day 0 (operation day)
Secondary outcomes:
measure: Detection of bacterial DNA in mesenteric lymph node
timeFrame: day 0 (operation day)
measure: Number of patients with surgical site infection (SSI)
timeFrame: outpatient visit, usually around 7 to 21 days before operation
measure: Modelling bacterial travel behaviour in multimodal networks
timeFrame: day 0
measure: Baseline skin and gut microbiota
timeFrame: outpatient visit, usually around 7 to 21 days before operation
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, University Hospital Bern, Visceral Surgery Department
Study officials:
affiliation: Inselspital, University Hospital of Bern
name: Guido Beldi, MD, Prof
role: STUDY_DIRECTOR
References: