The aim of the present study is to validate this model in a Dutch CD patient population.
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
correlation coefficient between CDEIS and new non-endoscopic index
Secondary outcome
nvt
Background summary
Crohn*s disease (CD) is a chronic inflammatory disease of the GI tract.
Clinical activity of the disease can be obtained by several questionnaires. The
most used activity score worldwide is the Crohn*s disease activity index
(CDAI). The disease activity score, reliably predicting endoscopical and
histological inflammatory activity, would make such cumbersome and unpleasant
procedures as endoscopies redundant. Recently, we developed this new disease
activity index which is expected to reliably predict endoscopic inflammation in
CD patients. We found that the following formula: number of liquid stools
during one day*0.25 + C-reactive protein (mg/L) *0.1 + platelet counts (109/L)
*0.01 + fecal calprotectin (mg/L) *0.001 - mean platelet volume (fL) *0.2
optimally predicts the severity of mucosal inflammation in CD patients. A good
correlation between the new activity index and the CDEIS was shown (r = 0.72; P
< 0.001).
Study objective
The aim of the present study is to validate this model in a Dutch CD patient
population.
Study design
Participating patients are asked to fill out the CDAI diary, the Inflammatory
Bowel Disease Questionnaire (IBDQ) and a demografic questionnaire before they
undergo ileocolonoscopy. In addition to the usual demographic data, details of
duration of disease, localization and behavior of the disease (Montreal
classification), current and previous medication use and previous surgeries
will be obtained from the medical records of the patients.
On the day of ileocolonoscopy blood samples, feces and urine are collected.
Ileocolonoscopy will be performed by the same endoscopist in all patients in
each participating hospital. Endoscopic disease activity will be assessed using
CDEIS (CD Endoscopic Index of severity). Representative parts of the ileum,
right colon (including cecum), transverse colon, left colon (including
sigmoid), and rectum will be recorded on videotape. An independent
gastroenterologist will score the disease activity by reviewing all videotapes.
Two biopsies will be taken from the most affected part of each segment.
Study burden and risks
Patients are asked to fill out three questionnaires which takes about 35
minutes, and to collect some feces.
Benefit: less often an indication for colonoscopy, which is a cumbersome
procedure.
heidelberglaan 100
3508 GA Utrecht
Nederland
heidelberglaan 100
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
18 years of age or older
diagnosis of CD for at least 6 months
a clinical indication for ileocolonoscopy
Exclusion criteria
A (sub)total colectomy
an ileostomy,
colostomy
active disease activity in the proximal part of the GI tract.
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 | NL23195.041.08 |