Analysis of INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes of the intestinal microbiome between start and end of surgery
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Changes of the intestinal microbiome between start and end of surgery
时间窗: 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.
次要结局
- 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))