- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Guido Beldi, MD, Prof
- Número de teléfono: 031 632 21 11
- Correo electrónico: guido.beldi@insel.ch
Ubicaciones de estudio
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-
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Bern, Suiza, 3008
- Reclutamiento
- Inselspital, University Hospital Bern, Visceral Surgery Department
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Contacto:
- Studer Peter, MD PhD
- Número de teléfono: +41316323194
- Correo electrónico: peter.studer@insel.ch
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Investigador principal:
- Guido Beldi, MD, Prof
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Sub-Investigador:
- Joel Zindel, MD
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Sub-Investigador:
- Peter Studer, MD PhD
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
SSI
This group receives an additional swab of the surgical site infection.
Follow up is terminated at the occurence of SSI.
|
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).
|
This is purely an observational study.
Groups SSI/No SSI are defined by the occurence of a surgical site infection.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Detection of bacterial DNA in liver biopsy
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Detection of bacterial DNA in mesenteric lymph node
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Guido Beldi, MD, Prof, Inselspital, University Hospital of Bern
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Bandit
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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