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临床试验/NCT04009954
NCT04009954Unknown不适用

Post-operative Ileus of Colorectal Cancer Patients Associated With Perioperative Gut Microbiota

First Affiliated Hospital of Harbin Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Change in gut microbiome dynamics in colorectal cancer patients during the perioperative period between two groups

研究概览

简要总结

Postoperative ileus (POI) is a common clinical condition after abdominal surgical procedure, leading to increased patient morbidity and prolonged hospitalisation.The mechanism of POI is not very clear until now. At the end of the 20th century, the inflammatory-mediated ileus hypothesis was introduced. But the initial trigger of the inflammatory cascade is unclear.Previous study demonstrate a clear association between colonic transit time, gut microbiota composition and urinary metabolic phenotype. Here the investigators suggest that the perioperative gut microbiota may contribute to POI.

详细描述

Postoperative ileus (POI) is a common clinical condition after abdominal surgical procedure, leading to increased patient morbidity and prolonged hospitalisation.

The clinical manifestations include abdominal distension, nausea, vomiting and the inability to pass stools or tolerate a solid diet. In addition to the discomfort experienced by patients, postoperative ileus is also an important risk factor for complications such as wound dehiscence and pulmonary and thromboembolic complications. Ileus was found to be an important predictor of extended postoperative hospital stays and costs in patients undergoing colectomy.

The mechanism of POI is not very clear until now. At the end of the 20th century, the inflammatory-mediated ileus hypothesis was introduced. But the initial trigger of the inflammatory cascade is unclear The innate immune system recognises two large classes of macromolecules: first, those related to pathogens or pathogen-associated molecular patterns (PAMPs), and secondly, molecules released in response to cell damage or damage-associated molecular patterns (DAMPs). The prototype of PAMPs is lipopolysaccharide (LPS), a constituent of the Gram-negative bacterial cell wall. Translocation of microbial products into the intestinal tissue is a well-documented feature in POI. Previous study demonstrate a clear association between colonic transit time, gut microbiota composition and urinary metabolic phenotype. Here the investigators suggest that the perioperative microbiome may contribute to POI. This study apply NGS(next generation sequencing) technique to analyse the composition of the perioperative gut microbiota of CRC(colorectal cancer) patients, then analysis the relationship between the dynamic variation of gut microbiota and POI.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Requirements of informed consent and assent of participant, parent or legal guardian as applicable
  • Patients with colorectal cancer scheduled for radical coloproctectomy and between the age of 35 and 80 years old without considering sex.
  • Patients with BMI= 18.5-23.9

排除标准

  • Patients with colorectal cancer with distant metastasis
  • Chronic renal diseases and hepatic cirrhosis
  • Chronic ischemic heart disease with unstable angina, chronic heart failure at class III or IV and acute myocardial infarction in the last 6 months
  • Individuals with a history of Chronic diarrhea
  • Individuals with a history of Diabetes mellitus
  • Individuals with a history of Hypertension
  • Individuals with a history of autoimmune diseases
  • Use of antibiotics and probiotics 3 mouth before samples collection
  • Individuals with a history of abdominal operation due to any reason
  • Individuals with any history of cancer other than colorectal cancer
  • Individuals with Inflammatory bowel disease

结局指标

主要结局

Change in gut microbiome dynamics in colorectal cancer patients during the perioperative period between two groups

时间窗: The day before operation day, the first to the 10th day after operation (everyday the patient's faeces will be collected for microbiome analysis, if the patient has no faeces,we will skip that day to next day for fecal collection)

The diversity, structure of fecal microbiota and relative abundance of special bacterial taxa 16S rRNA gene sequencing will be performed.

The time ranging from operation day to the day of first defecation

时间窗: Up to 10 days

The recovery of gut transit can be indicated by the first defecation

次要结局

  • Concentration of plasma i-FABP(intestinal fatty acid-binding protein)(The day before operation day, every day from first to fifth post-operative day)
  • Concentration of fecal LPS(The day before operation day, the first to the 10th day after operation (everyday the patient's faeces will be collected for microbiome analysis, if the patient has no faeces,we will skip that day to next day for fecal collection))
  • Concentration of fecal calprotectin(The day before operation day, the first to the 10th day after operation (everyday the patient's faeces will be collected for microbiome analysis, if the patient has no faeces,we will skip that day to next day for fecal collection))
  • Concentration of plasma LPS(The day before operation day, every day from first to fifth post-operative day)

研究者

发起方
First Affiliated Hospital of Harbin Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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