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- Klinische proef NCT03554148
Bacteria and Intestinal Translocation in Surgery (Bandit) (Bandit)
Assessment of Bacterial Translocation on the Incidence of Surgical Site Infection in Abdominal Surgery: Prospective Cohort Study.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Guido Beldi, MD, Prof
- Telefoonnummer: 031 632 21 11
- E-mail: guido.beldi@insel.ch
Studie Locaties
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Bern, Zwitserland, 3008
- Werving
- Inselspital, University Hospital Bern, Visceral Surgery Department
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Contact:
- Studer Peter, MD PhD
- Telefoonnummer: +41316323194
- E-mail: peter.studer@insel.ch
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Hoofdonderzoeker:
- Guido Beldi, MD, Prof
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Onderonderzoeker:
- Joel Zindel, MD
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Onderonderzoeker:
- Peter Studer, MD PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
SSI
This group receives an additional swab of the surgical site infection.
Follow up is terminated at the occurence of SSI.
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This is purely an observational study.
Groups SSI/No SSI are defined by the occurence of a surgical site infection.
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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).
|
This is purely an observational study.
Groups SSI/No SSI are defined by the occurence of a surgical site infection.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Detection of bacterial DNA in liver biopsy
Tijdsspanne: 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). |
day 0 (operation day)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Detection of bacterial DNA in mesenteric lymph node
Tijdsspanne: 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). |
day 0 (operation day)
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Number of patients with surgical site infection (SSI)
Tijdsspanne: outpatient visit, usually around 7 to 21 days before operation
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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.
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outpatient visit, usually around 7 to 21 days before operation
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Modelling bacterial travel behaviour in multimodal networks
Tijdsspanne: day 0
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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. |
day 0
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Baseline skin and gut microbiota
Tijdsspanne: outpatient visit, usually around 7 to 21 days before operation
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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. |
outpatient visit, usually around 7 to 21 days before operation
|
Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Guido Beldi, MD, Prof, Inselspital, University Hospital of Bern
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Bandit
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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