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

Bacteria and Intestinal Translocation in Surgery (Bandit)



Sponsors


Source

University Hospital Inselspital, Berne

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2017-07-01

Completion Date

2021-12-31

Primary Completion Date

2021-12-31

Study Type

Observational

Primary Outcome

Measure

Time Frame

Detection of bacterial DNA in liver biopsy
day 0 (operation day)

Secondary Outcome

Measure

Time Frame

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

Number Of Groups

2

Enrollment

209

Condition


Intervention

Intervention Type

Other

Intervention Name


Description

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

Arm Group Label

SSI

No SSI



Eligibility

Study Pop

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

Sampling Method

Non-Probability Sample

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

Gender

All

Minimum Age

18 Years

Maximum Age

N/A


Overall Official

Last Name

Role

Affiliation

Guido Beldi, MD, Prof
Study Director
Inselspital, University Hospital of Bern

Overall Contact

Last Name

Guido Beldi, MD, Prof

Phone

031 632 21 11

Email



Location

Facility

Status

Contact

Investigator

Inselspital, University Hospital Bern, Visceral Surgery Department
Bern 3008 Switzerland
Recruiting
Last Name: Joel Zindel, MD
Phone: +41316322746
Email: [email protected]
Last Name: Guido Beldi, MD, Prof
Role: Principal Investigator

Last Name: Zindel Joel, MD
Role: Sub-Investigator


Location Countries

Country

Switzerland


Verification Date

2018-06-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

SSI

Description

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


Arm Group Label

No SSI

Description

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).



Firstreceived Results Date

N/A

Acronym

Bandit

Patient Data

Sharing Ipd

Undecided


Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Prospective


Study First Submitted

November 9, 2017

Study First Submitted Qc

June 11, 2018

Study First Posted

June 12, 2018

Last Update Submitted

June 11, 2018

Last Update Submitted Qc

June 11, 2018

Last Update Posted

June 12, 2018


ClinicalTrials.gov processed this data on June 12, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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