An observational study on the presence of inflammatory changes in the mucosa of the sigmoid colon in asymptomatic individuals with diverticular disease and the correlation with colon microbiology
- Conditions
- Diverticular diseasediverticulosis10013535
- Registration Number
- NL-OMON36560
- Lead Sponsor
- Kennemer Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
• Eighteen years or older;
• Scheduled for colonoscopy for:
1. Hematochezia;
2. gastrointestinal hemorrhage;
3. unexplained changes in bowel habit;
4. weight loss;
5. iron-deficiency anemia;
6. chronic obstipation without positive reaction on the treatment;
7. screening for and follow-up of colorectal cancer;
• Suspicion of diverticular related complaints;
• Proven history of symptomatic diverticular disease;
• Use of coumarin derivates, unless stopped one week before colonoscopy;
• Use of NSAID*s unless stopped one week before colonoscopy;
• Use of platelet aggregate inhibitors, including aspirin, unless stopped one week before colonoscopy;
• Sedation before informed consent;
• History of inflammatory bowel disease;
• Endoscopic signs of inflammation.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Inflammation, defined as mean T lymphocyte count and neutrophil count in the<br /><br>mucosa of the colon. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Colonic flora, expressed as anaerobic/ aerobic ratio and presence or absence of<br /><br>certain strains of bacteria by means of micro-array.</p><br>