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

17 de mayo de 2022 actualizado por: University Hospital Inselspital, Berne

Assessment of Bacterial Translocation on the Incidence of Surgical Site Infection in Abdominal Surgery: Prospective Cohort Study.

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.

Descripción general del estudio

Estado

Reclutamiento

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Anticipado)

209

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Guido Beldi, MD, Prof
  • Número de teléfono: 031 632 21 11
  • Correo electrónico: guido.beldi@insel.ch

Ubicaciones de estudio

      • Bern, Suiza, 3008
        • Reclutamiento
        • Inselspital, University Hospital Bern, Visceral Surgery Department
        • Contacto:
        • Investigador principal:
          • Guido Beldi, MD, Prof
        • Sub-Investigador:
          • Joel Zindel, MD
        • Sub-Investigador:
          • Peter Studer, MD PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

N/A

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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)
Number of patients with surgical site infection (SSI)
Periodo de tiempo: 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.
outpatient visit, usually around 7 to 21 days before operation
Modelling bacterial travel behaviour in multimodal networks
Periodo de tiempo: 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.

day 0
Baseline skin and gut microbiota
Periodo de tiempo: 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.

outpatient visit, usually around 7 to 21 days before operation

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Director de estudio: Guido Beldi, MD, Prof, Inselspital, University Hospital of Bern

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de julio de 2017

Finalización primaria (Anticipado)

31 de diciembre de 2025

Finalización del estudio (Anticipado)

31 de diciembre de 2025

Fechas de registro del estudio

Enviado por primera vez

9 de noviembre de 2017

Primero enviado que cumplió con los criterios de control de calidad

11 de junio de 2018

Publicado por primera vez (Actual)

12 de junio de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de mayo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

17 de mayo de 2022

Última verificación

1 de mayo de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Bandit

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre No intervention

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