Bacteria and Intestinal Translocation in Surgery (Bandit)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Surgical Site Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SSI

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

No intervention

Intervention Type OTHER

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

No SSI

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).

No intervention

Intervention Type OTHER

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

Interventions

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No intervention

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No