Condition or disease | Intervention/treatment |
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Post-operative Ileus | Other: Fecal and blood samples collection for analysis |
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.
Study Type : | Observational |
Estimated Enrollment : | 40 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | Post-operative Ileus of Colorectal Cancer Patients Associated With Perioperative Gut Microbiota |
Actual Study Start Date : | April 1, 2019 |
Estimated Primary Completion Date : | September 30, 2020 |
Estimated Study Completion Date : | December 31, 2020 |
Group/Cohort | Intervention/treatment |
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Delayed transit
CRC patients with delayed gut transit recovery( first time defecation >3 day )
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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).
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Normal transit
CRC patients with normal gut transit recovery( first time defecation <=3 day )
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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).
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Ages Eligible for Study: | 35 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yunwei Wei, professor | +86045185553099 | hydwyw11@hotmail.com | |
Contact: Yang Liu, assistant research fellow | +8618345180169 | lyang712@icloud.com |
China, Heilongjiang | |
First affiliated hospital of Harbin medical university | Recruiting |
Harbin, Heilongjiang, China, 150001 | |
Contact: Yunwei Wei +86-0451-85553099 hydwyw11@hotmail.com |
Study Director: | Yunwei Wei | First Affiliated Hospital of Harbin Medical University |
Tracking Information | |||||
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First Submitted Date | May 13, 2019 | ||||
First Posted Date | July 8, 2019 | ||||
Last Update Posted Date | July 8, 2019 | ||||
Actual Study Start Date | April 1, 2019 | ||||
Estimated Primary Completion Date | September 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Post-operative Ileus and Gut Microbiota | ||||
Official Title | Post-operative Ileus of Colorectal Cancer Patients Associated With Perioperative Gut Microbiota | ||||
Brief 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. | ||||
Detailed 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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description:
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).
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Sampling Method | Non-Probability Sample | ||||
Study Population | Study participants are patients need undergo an exhaustive colorectal cancer surgical resection in the First Affiliated Hospital of Harbin Medical University from May 1, 2018 to Dec 31, 2019. | ||||
Condition | 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).
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
40 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 31, 2020 | ||||
Estimated Primary Completion Date | September 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 35 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04009954 | ||||
Other Study ID Numbers | Yunwei Wei 2019-04-19 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | First Affiliated Hospital of Harbin Medical University | ||||
Study Sponsor | First Affiliated Hospital of Harbin Medical University | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | First Affiliated Hospital of Harbin Medical University | ||||
Verification Date | April 2019 |