Analysis of the Composition of the Intestinal Microbiota and Its Evolution in Patients Post-intestinal Anastomosis
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Understand the patient's microbiome
概览
简要总结
Recent research suggests a significant link between gut microbiota and anastomotic leakage (AL) in colorectal surgery. Patients who develop AL have a higher abundance of bacteria from the Lachnospiraceae family and lower microbial diversity.
Considering the bibliographic data, our main interest is to analyze the microbial population of patients in our social environment and then look for differences in the microbiome between those who have suffered an anastomotic dehiscence (around 8-9% according to the results of our hospital's Surgery Department) and those who have not.
详细描述
The study is designed as a prospective, descriptive, non-interventional research project in which some variables will be analyzed transversally. Patients will be selected by the clinical members of the research team from within the population in our setting who will undergo abdominal surgery involving colorectal intestinal anastomosis. Once accepted, stool samples will be requested prior to surgical preparation, during surgery, and afterwards to determine their microbiome; in this way, we will attempt to correlate the evolution of their anastomosis with their intestinal bacterial population.
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
- •Patients who have undergone colorectal intestinal anastomosis.
- •Signing of the informed consent form.
- •Age ≥18 years with good functional status.
- •Availability for postoperative follow-up.
排除标准
- •Emergency surgery.
- •Intra-abdominal sepsis or previous dehiscence.
- •Severe immunosuppression.
- •Use of antibiotics in the 3 months prior to preoperative preparation.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Patients undergoing abdominal surgery with intestinal anastomosis
Older than 18 years of age
干预措施: Not applicable- observational study (Other)
结局指标
主要结局
Understand the patient's microbiome
时间窗: From enrollment to a month post surgery
To understand the microbiome of patients undergoing colorectal surgery and the effect of current surgical preparation on the microbiota in our local population.
次要结局
- Predictive indicators of colorectal anastomosis postsurgery(From surgery to a month)
研究者
Mariano Garcia Arranz
Doctor of Biochemistry and Molecular Biology
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz