INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery - Trial NCT05775341
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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Study Focus
Sponsor & Location
University Hospital Inselspital, Berne
Timeline & Enrollment
N/A
Feb 27, 2023
Dec 31, 2026
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
Data Source
ClinicalTrials.gov
NCT05775341
Non-Device Trial