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Bacteria and Intestinal Translocation in Surgery (Bandit) (Bandit)

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ClinicalTrials.gov Identifier: NCT03554148
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Insel Gruppe AG, University Hospital Bern

Study Description
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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.

Condition or disease Intervention/treatment
Surgical Site Infection Other: No intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 209 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Bacterial Translocation on the Incidence of Surgical Site Infection in Abdominal Surgery: Prospective Cohort Study.
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025
Groups and Cohorts
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Group/Cohort Intervention/treatment
SSI
This group receives an additional swab of the surgical site infection. Follow up is terminated at the occurence of SSI.
 Other: No intervention
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).
 Other: No intervention
This is purely an observational study. Groups SSI/No SSI are defined by the occurence of a surgical site infection.


Outcome Measures
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Primary Outcome Measures :
  1. Detection of bacterial DNA in liver biopsy [ Time Frame: day 0 (operation day) ]

    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).



Secondary Outcome Measures :
  1. Detection of bacterial DNA in mesenteric lymph node [ Time Frame: day 0 (operation day) ]

    Rationale: To address the interstitial translocation and drainage of microbes during colonic surgery. Positive lymph nodes are a surrogate marker of SSI. However, positive lymph nodes may just be a surrogate a marker of a high amount of bacteria being translocated from intestinal lumen to the interstitial space during surgery. Or, mesenteric lymph nodes truly are a significant line of defence against surgical site infections.

    Sampling: A lymph node is sampled from the resected specimen within the OR under sterile conditions. The lymph node is excised. Half of this lymph node is sampled for research purposes, the other half is marked with a suture and sent for pathological evaluation with the rest of the specimen.

    Processing: Sample is immediately snap-frozen in liquid nitrogen. Storage: Biobank: -80°C. Analysis: same as liver biopsy. The difference in positive/negative lymph node probes is compared for patients with and without surgical site infections (Chi squared Test).


  2. Number of patients with surgical site infection (SSI) [ Time Frame: outpatient visit, usually around 7 to 21 days before operation ]
    The number of patients with surgical site infection are recoded. Surgical site infection is defined according to the Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017.

  3. Modelling bacterial travel behaviour in multimodal networks [ Time Frame: day 0 ]

    Rationale: The way bacteria travel from places they grow in abundance(gut,skin), ending up in a surgical site to cause infection, has not been studied.

    Sampling: In addition to the preoperative skin and rectal swab and the intraoperative liver and lymph node biopsy, additional samples are collected in a prospective manner: biopsy of the visceral peritoneum, parietal peritoneum, intestinal mucosa and skin. Swab of intestinal content. Venous blood. All samples are handled sterile and are immediately frozen in liquid nitrogen and stored at -80°C.

    Analysis: For the surgical site infections subgroup, samples are analyzed as described above(bacteria specific PCR followed by Sequencing). The sequencing results translate tinto abundance of families/species. Multimodal networks are applied to describe the potential travel behaviour of bacteria.


  4. Baseline skin and gut microbiota [ Time Frame: outpatient visit, usually around 7 to 21 days before operation ]

    The baseline gut and skin microbiota are metagenomically characterized on the basis of 16S rRNA genomic DNA sequencing.

    Statistical analysis: Differences of skin and gut microbiota between patients with and without surgical site infections are compared using PerMANOVA. The correlation between distinct microbiota (families or clusters) and the occurence surgical site infections is tested using multiple logistic regressions.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients undergoing elective visceral surgery. Mostly for oncological indications.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554148


Contacts
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Contact: Guido Beldi, MD, Prof 031 632 21 11 guido.beldi@insel.ch

Locations
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Switzerland
Inselspital, University Hospital Bern, Visceral Surgery Department Recruiting
Bern, Switzerland, 3008
Contact: Studer Peter, MD PhD    +41316323194    peter.studer@insel.ch   
Principal Investigator: Guido Beldi, MD, Prof         
Sub-Investigator: Joel Zindel, MD         
Sub-Investigator: Peter Studer, MD PhD         
Sponsors and Collaborators
Insel Gruppe AG, University Hospital Bern
Investigators
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Study Director: Guido Beldi, MD, Prof Inselspital, University Hospital of Bern
More Information
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Responsible Party: Insel Gruppe AG, University Hospital Bern
ClinicalTrials.gov Identifier: NCT03554148    
Other Study ID Numbers: Bandit
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes