Bacteria and Intestinal Translocation in Surgery (Bandit)

NCT03554148 | Active Not Recruiting

• 1 other identifier: Bandit
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Detection of bacterial DNA in liver biopsy

  Rationale: One of the aims is to test how the liver acts as primary barrier for blood-borne bacteria during the operation. Sampling: During elective abdominal surgery a biopsy with the Tru-Cut™ Needle (Baxter healthcare Co., 16G Chicago, USA) is performed as recommended by the manufacturer. Hemostasis is achieved by Application of mono-polar Electrocautery. Processing: The sample is immediately snap-frozen in liquid nitrogen. Storage: Biobank: -80°C. Analysis: Polymerase chain reaction (PCR) with bacteria specific primers, Sequencing of the PCR product (IonTorrent) to determine the present microbiota (species if possible, at least families). The difference in positive/negative liver probes is compared for patients with and without surgical site infections (Chi squared Test).

  day 0 (operation day)

Secondary Outcomes (4)

• Detection of bacterial DNA in mesenteric lymph node

  day 0 (operation day)

• Number of patients with surgical site infection (SSI)

  outpatient visit, usually around 7 to 21 days before operation

• Modelling bacterial travel behaviour in multimodal networks

  day 0

• Baseline skin and gut microbiota

  outpatient visit, usually around 7 to 21 days before operation

Study Arms (2)

SSI

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

Other: No intervention

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).

Other: No intervention

Interventions

No intervention OTHER

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

No SSI; SSI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing elective visceral surgery. Mostly for oncological indications.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, University Hospital Bern, Visceral Surgery Department

Bern, 3008, Switzerland

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guido Beldi, MD, Prof

  Inselspital, University Hospital of Bern

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: June 12, 2018
• Study Start: July 1, 2017
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CH (1)