INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery

Recruiting

• Conditions: Surgical Site Infection

• Registration Number: NCT05775341
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-27
• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Bacterial taxonomy in the intestine	Day 0 (Day of Surgery)	Bacterial taxonomy in the intestine at start (T1) and end (T2) of surgery
Bacterial taxonomy MLN	Day 0 (Day of Surgery)	Bacterial taxonomy MLN end (T2) of surgery
Bacterial taxonomy mucosal swabs	Day 0 (Day of Surgery)	Bacterial taxonomy mucosal swabs at start (T1) and end (T2) of surgery
Bacterial taxonomy in the blood	Day 0 (Day of Surgery)	Bacterial taxonomy in the blood at start (T1) and end (T2) of surgery

Trial Locations

Locations (1)

Beldi Guido; 🇨🇭 Bern, Switzerland