INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery

NCT05775341 | Active Not Recruiting

• 1 other identifier: 2022-01054
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Bacterial taxonomy in the intestine

  Day 0 (Day of Surgery)

• Bacterial taxonomy MLN

  Day 0 (Day of Surgery)

• Bacterial taxonomy mucosal swabs

  Day 0 (Day of Surgery)

• Bacterial taxonomy in the blood

  Day 0 (Day of Surgery)

Interventions

No Intervention OTHER

This is purely an observational study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing elective abdominal surgery

You may qualify if:

• Patients undergoing laparoscopic colorectal resection with anastomosis or patients undergoing duodeno-pancreatectomy.
• Elective surgery
• Informed consent
• Age \> 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Beldi Guido

Bern, 3008, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Mucosal swabs, intestinal mucosa and content, serum, mesenteric lymph node, subcutaneous biopsy

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guido Beldi

  Department of Visceral Surgery and Medicine, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: February 27, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)