INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery (INTRA)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Surgical Site Infection
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3008
    • Beldi Guido

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing elective abdominal surgery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of the intestinal microbiome between start and end 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.	Day 0 (Day of Surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial taxonomy in the intestine	Bacterial taxonomy in the intestine at start (T1) and end (T2) of surgery	Day 0 (Day of Surgery)
Bacterial taxonomy MLN	Bacterial taxonomy MLN end (T2) of surgery	Day 0 (Day of Surgery)
Bacterial taxonomy mucosal swabs	Bacterial taxonomy mucosal swabs at start (T1) and end (T2) of surgery	Day 0 (Day of Surgery)
Bacterial taxonomy in the blood	Bacterial taxonomy in the blood at start (T1) and end (T2) of surgery	Day 0 (Day of Surgery)

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Guido Beldi, Department of Visceral Surgery and Medicine, Bern University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection
• Other Study ID Numbers: 2022-01054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No