INTRA: INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery
Study Details
Study Description
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:
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Patients undergoing surgery develop transient intestinal dysbiosis
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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:
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Perioperative: Baseline health data, nutrition data, measurement body composition, glucose monitoring
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Intraoperatively:
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Mucosal swabs
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Blood from central venous catheter and portal vein
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Mesenteric lymph node
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Intestinal specimen
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Subcutaneous biopsy
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Postoperatively:
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If a surgical site infection occurs samples from infected site
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion criteria:
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Patients undergoing laparoscopic colorectal resection with anastomosis or patients undergoing duodeno-pancreatectomy.
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Elective surgery
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Informed consent
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Age > 18 years
Exclusion criteria:
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Antibiotic treatment 30 days prior to surgery
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Emergency surgery
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Other surgery 30 days prior to colorectal surgery
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Neoadjuvant radio- or chemotherapy
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BMI <18 or >40kg/m2
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Cholestasis, hepatic or renal disease
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Immunosuppression
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Inflammatory bowel disease
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Any form of enteritis or colitis, malabsorption, enteric infections
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Pancreatitis
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Indication for intravenous anesthesia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beldi Guido | Bern | Switzerland | 3008 |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
Investigators
- Principal Investigator: Guido Beldi, Department of Visceral Surgery and Medicine, Bern University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-01054