The primary objective is to evaluate the presence of inflammation in the mucosa around diverticula in the sigmoid colon in patients without clinical symptoms of diverticular disease and without endoscopic evidence of inflammation. This is compared…
ID
Source
Brief title
Condition
- Diverticular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Inflammation, defined as mean T lymphocyte count and neutrophil count in the
mucosa of the colon.
Secondary outcome
Colonic flora, expressed as anaerobic/ aerobic ratio and presence or absence of
certain strains of bacteria by means of micro-array.
Background summary
Approximately 10 to 25% of patients with diverticular disease will eventually
develop an episode of acute diverticulitis. The pathogenesis of diverticulitis
remains unclear. Rather than the original hypothesis that all forms of
diverticulitis arise from a microperforation, recent research shows that
chronic low-grade inflammation caused by an altered colonic flora may play a
role.
Study objective
The primary objective is to evaluate the presence of inflammation in the mucosa
around diverticula in the sigmoid colon in patients without clinical symptoms
of diverticular disease and without endoscopic evidence of inflammation. This
is compared to other parts of the colon not affected by diverticula and to
pathology specimens taken from the sigmoid colon mucosa of individuals without
diverticulosis on colonoscopy. Furthermore we will evaluate the correlation
between mucosal inflammation and colonic microbiology.
Study design
The proposed study is an observational study in which a cohort of patients with
endoscopy confirmed diverticulosis is compared to a cohort of patients without
diverticulosis at endoscopy.
Study burden and risks
There is no specific benefit for individual patients in this study as it
involves fundamental research on the pathogenesis of diverticular disease and
diverticulitis that may guide further research on prevention and treatment. The
risk associated with taking biopsies is considered low. Bleeding and
perforation are the two main concerns. Some form of rectal blood loss after
biopsy is reported in 0.2% to 3,4% of patients of which 0,1% required
admittance to the hospital. Perforation is very rare with incidences ranging
from 0.07% to 0.72% in all colonoscopies. To minimize the risk of bleeding,
patients with anti-coagulant medication are excluded from participation in our
study.
Postbus 417
2000 AK
NL
Postbus 417
2000 AK
NL
Listed location countries
Age
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
• 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32966.094.10 |