Bacteria and Intestinal Translocation in Surgery (Bandit)

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Surgical Site Infection

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT03554148

Bandit

Details and patient eligibility

About

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.

Enrollment: 209 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

209 participants in 2 patient groups

SSI

Description:

This group receives an additional swab of the surgical site infection. Follow up is terminated at the occurence of SSI.

Treatment:

Other: No intervention

No SSI

Description:

This group is systematically followed up until 30 days after surgery (one year if a implant is implanted, e.g. mesh) by a third party (www.swissnoso.ch).

Treatment:

Other: No intervention