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ACTIVE NOT RECRUITING
NCT03554148

Bacteria and Intestinal Translocation in Surgery (Bandit)

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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.

Official title: Assessment of Bacterial Translocation on the Incidence of Surgical Site Infection in Abdominal Surgery: Prospective Cohort Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

209

Start Date

2017-07-01

Completion Date

2026-12-31

Last Updated

2026-05-05

Healthy Volunteers

Not specified

Interventions

OTHER

No intervention

This is purely an observational study. Groups SSI/No SSI are defined by the occurence of a surgical site infection.

Locations (1)

Inselspital, University Hospital Bern, Visceral Surgery Department

Bern, Switzerland