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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

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 - PADIFLORA study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36560
Enrollment
40
Registered
2011-01-17
Start date
2011-06-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diverticular disease diverticulosis

Interventions

None listed

Sponsors

Kennemer Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • 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;

Exclusion criteria

Exclusion criteria: • 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.

Design outcomes

Primary

MeasureTime frame
Inflammation, defined as mean T lymphocyte count and neutrophil count in the mucosa of the colon.

Secondary

MeasureTime frame
Colonic flora, expressed as anaerobic/ aerobic ratio and presence or absence of certain strains of bacteria by means of micro-array.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)