Post-operative IleusNCT04009954
Post-operative Ileus and Gut Microbiota
An observational study of Post-operative Ileus, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Post-operative Ileus
- What is being tested?
- Fecal and blood samples collection for analysis
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001
Yunwei Wei, +86-0451-85553099, hydwyw11@hotmail.com
About this study
Official title: Post-operative Ileus of Colorectal Cancer Patients Associated With Perioperative Gut Microbiota
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.
Read the 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.
- Conditions
- Post-operative Ileus
- Being tested
- Fecal and blood samples collection for analysis
- Keywords
- Post-operative Ileus, Gut Microbiota, perioperative period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal and blood samples collection for analysisOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Delayed transit | CRC patients with delayed gut transit recovery( first time defecation >3 day ) Receives: Other: Fecal and blood samples collection for analysis | |
| Normal transit | CRC patients with normal gut transit recovery( first time defecation <=3 day ) Receives: Other: Fecal and blood samples collection for analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 time ranging from operation day to the day of first defecation
The recovery of gut transit can be indicated by the first defecation
Measured: Up to 10 days
Secondary outcomes (4)
Concentration of plasma i-FABP(intestinal fatty acid-binding protein)
The detection of i-FABP is useful to determine localized changes in intestinal damage.
Measured: The day before operation day, every day from first to fifth post-operative day
Concentration of plasma LPS
The presence of lipopolysaccharide (LPS) has been used as an indirect measurement of bacterial translocation and systemic exposure to bacteria.
Measured: The day before operation day, every day from first to fifth post-operative day
Concentration of fecal LPS
LPS was derived from gram-negative bacteria in the intestinal tract, and LPS in blood was derived from feces.
Measured: 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
Fecal calprotectin is not only an indicator of intestinal inflammation, but also an indicator of intestinal mucosal barrier.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Apr 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunwei Wei, Study director, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009954
- Sponsor's protocol ID
- Yunwei Wei 2019-04-19
- Status last verified
- Apr 2019
- First submitted
- 13 May 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Ileus of Colorectal Cancer Patients Associated With Perioperative Gut Microbiota
- ClinicalTrials.gov ID
- NCT04009954
- Acronym / sponsor ID
- Yunwei Wei 2019-04-19
- Conditions
- Post-operative Ileus
- Keywords
- Post-operative Ileus, Gut Microbiota, perioperative period
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed transit | – | Other: Fecal and blood samples collection for analysisCRC patients with delayed gut transit recovery( first time defecation >3 day ) |
| Normal transit | – | Other: Fecal and blood samples collection for analysisCRC patients with normal gut transit recovery( first time defecation <=3 day ) |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal and blood samples collection for analysisFecal 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). | Other | Delayed transit, Normal transit |
Primary outcome
Change in gut microbiome dynamics in colorectal cancer patients during the perioperative period between two groups
Time frame: 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
Time frame: Up to 10 days
The recovery of gut transit can be indicated by the first defecation
4 secondary outcomes
Concentration of plasma i-FABP(intestinal fatty acid-binding protein)
Time frame: The day before operation day, every day from first to fifth post-operative day
Concentration of plasma LPS
Time frame: The day before operation day, every day from first to fifth post-operative day
Concentration of fecal LPS
Time frame: 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
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunwei Wei study director
First Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Ileus, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunwei Wei, professor (+86045185553099, hydwyw11@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut microbiome dynamics in colorectal cancer patients during the perioperative period between two groups (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.