INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery

Study Overview
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Brief Summary
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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

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

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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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 colorectal 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No Intervention|This is purely an observational study.|

What is the study measuring?
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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) |