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INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05775341
Acronym
INTRA
Enrollment
120
Registered
2023-03-20
Start date
2023-02-27
Completion date
2026-12-31
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

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

Interventions

OTHERNo Intervention

This is purely an observational study.

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Changes of the intestinal microbiome between start and end of surgeryDay 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

MeasureTime frameDescription
Bacterial taxonomy in the intestineDay 0 (Day of Surgery)Bacterial taxonomy in the intestine at start (T1) and end (T2) of surgery
Bacterial taxonomy MLNDay 0 (Day of Surgery)Bacterial taxonomy MLN end (T2) of surgery
Bacterial taxonomy mucosal swabsDay 0 (Day of Surgery)Bacterial taxonomy mucosal swabs at start (T1) and end (T2) of surgery
Bacterial taxonomy in the bloodDay 0 (Day of Surgery)Bacterial taxonomy in the blood at start (T1) and end (T2) of surgery

Countries

Switzerland

Contacts

PRINCIPAL_INVESTIGATORGuido Beldi

Department of Visceral Surgery and Medicine, Bern University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026