NCT05775341

INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery

Name: Clinical Trial NCT05775341
Creator: University Hospital Inselspital, Berne
Keywords: Surgical Site Infection, No Intervention, other, clinical trial, Switzerland

Analysis of INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Abdominal Surgery

University Hospital Inselspital, Berne·ClinicalTrials.gov·otherRecruiting

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Study focus

Disease/Condition: Surgical Site Infection
Drug/Device/Intervention: No Intervention
Study type: Observational
Intervention type: other

Sponsor & location

Primary sponsor: University Hospital Inselspital, Berne
Location: Bern, Switzerland

Timeline & enrollment

Phase: N/A
Start date: Feb 27, 2023
End date: Dec 31, 2026
Enrollment: 120 participants

Primary outcome

Changes of the intestinal microbiome between start and end of surgery

Summary

The goal of this observational study is to contribute to a better understanding of the perioperative kinetics of intestinal microbial composition and association with surgical site infections.  The main question this study aims to determine if:  - Patients undergoing surgery develop transient intestinal dysbiosis  - Such transient dysbiosis is associated with translocation to the systemic circulation and surgical site infection  Patients undergoing elective abdominal surgery will be included prospectively. Informed consent will be obtained. From patients the following information and samples will be collected:  - Perioperative: Baseline health data, nutrition data, measurement body composition, glucose monitoring  - Intraoperatively:  - Mucosal swabs  - Blood from central venous catheter and portal vein  - Mesenteric lymph node  - Intestinal specimen  - Subcutaneous biopsy  - Postoperatively:  - If a surgical site infection occurs samples from infected site

ICD-10 classifications

Infection following a procedure, not elsewhere classifiedBacterial infection of unspecified siteOther bacterial infections of unspecified siteInfection of obstetric surgical woundOther specified local infections of skin and subcutaneous tissue

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05775341
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05775341 through Pure Global AI's free database. This phase not specified trial is sponsored by University Hospital Inselspital, Berne and is currently Recruiting. The study focuses on Surgical Site Infection. Target enrollment is 120 participants.

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