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Clinical Trials in Switzerland / NCT05775341
Active, not recruiting Observational

INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery

NCT05775341 · tracked via the Priya Life Science Switzerland tracker
Sponsor
Insel Gruppe AG, University Hospital Bern
Phase
Observational
Started
2023-02-27
Last updated
2026-04-29

Condition(s) studied

Surgical Site Infection

Investigational drug(s) / intervention(s)

No Intervention

No Intervention: This is purely an observational study.

Study 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
* Bile
* Subcutaneous biopsy
* Postoperatively:

* If a surgical site infection occurs samples from infected site

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: * Patients undergoing laparoscopic colorectal resection with anastomosis or patients undergoing duodeno-pancreatectomy. * Elective surgery * Informed consent * Age \> 18 years Exclusion criteria: * Emergency surgery * Other surgery 30 days prior to surgery * BMI \<18 or \>50kg/m2 * Planed simultaneous second procedure with involvement of the intestinal tract * Cholestasis with cholangitis, hepatic disease (defined as cirrhosis Child B or C) or renal disease (acute or chronic renal failure defined as eGFR≤ 30ml/min) * Severe active enteritis or colitis, malabsorption, enteric infections * Pancreatitis

Primary outcome measure(s)

  • Changes of the intestinal microbiome between start and end of surgery — Day 0 (Day of Surgery)
    Score between PCA (principal components analysis) in the intestine between start (T1) and end (T2) of surgery. * Sampling: An intestinal specimen is dissected at start and end of elective pancreatic resections. * Processing: Samples are immediately processed for storage at -80° in glycerol. * Analysis: Quantification of total Biomass, DNA extraction, preparation of Bacterial DNA libraries, sequencing with Illumina system, downstream analysis, statistical analysis, principal components analysis (PCA) with all the samples is performed and the score is defined based on the distance between the two centers in PC1 and PC2 of T1 versus T2.

Trial sites (1)

FacilityCityRegionStatus
Beldi Guido Bern Switzerland

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Other trials for the same condition

Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery Recruiting
Bacteria and Intestinal Translocation in Surgery (Bandit) Active, not recruiting
Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery Starting soon
The Inselspital Surgical Cohort Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05775341 on ClinicalTrials.gov ↗ ← All trials in Switzerland