Post-operative Ileus and Gut Microbiota

Post-operative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04009954
• Other study ID #: Yunwei Wei 2019-04-19
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2019
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Yunwei Wei, professor
• Phone: +86045185553099
• Email: hydwyw11[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ileus
• Post-operative Ileus

Intervention

Other:
• Fecal and blood samples collection for analysis
Fecal sample analysis will consist of the following procedure : Microbial DNA extraction, amplicon library construction, sequencing and analysis; Clustering "MiSeq" reads into operational taxonomic units (OTUs).

Locations

Country	Name	City	State
China	First affiliated hospital of Harbin medical university	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gut microbiome dynamics in colorectal cancer patients during the perioperative period between two groups	The diversity, structure of fecal microbiota and relative abundance of special bacterial taxa 16S rRNA gene sequencing will be performed.	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)
Primary	The time ranging from operation day to the day of first defecation	The recovery of gut transit can be indicated by the first defecation	Up to 10 days
Secondary	Concentration of plasma i-FABP(intestinal fatty acid-binding protein)	The detection of i-FABP is useful to determine localized changes in intestinal damage.	The day before operation day, every day from first to fifth post-operative day
Secondary	Concentration of plasma LPS	The presence of lipopolysaccharide (LPS) has been used as an indirect measurement of bacterial translocation and systemic exposure to bacteria.	The day before operation day, every day from first to fifth post-operative day
Secondary	Concentration of fecal LPS	LPS was derived from gram-negative bacteria in the intestinal tract, and LPS in blood was derived from feces.	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)
Secondary	Concentration of fecal calprotectin	Fecal calprotectin is not only an indicator of intestinal inflammation, but also an indicator of intestinal mucosal barrier.	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)