Inflammatory Bowel Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inflammatory Bowel Disease (IBD) (Crohn*s disease (CD) or ulcerative colitis (UC)) patients who are planned to undergo a routine IBD colonoscopy with the collection of biopsies for disease activity assessment; >=18 years old; active disease (defined as Mayo>1 for UC or SES-CD>2 for CD); ability to provide informed consent.
Exclusion criteria
Exclusion criteria: Complete remission; history of colonic perforation during endoscopic procedures; active use of anticoagulant medications; familial history of bleeding disorders; known individual bleeding disorders; suspicion of dysplasia or colorectal carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sample quality will be assessed based on the measure of cell yield, which quantifies the number of cells obtained in the biopsy samples. A higher cell yield typically indicates better sample quality, making it a key metric for evaluating the effectiveness of the biopsy procedures. In addition, the different cell types present in the biopsies will be analysed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Significant intra-procedural bleeding: as objectified by the endoscopist Post-procedural bleeding: defined as rectal blood-loss that requires re-colonoscopy: persistent bleeding (>2 days after procedure) Perforation (objectified on cross-sectional imaging) Infection: defined as formation of an abscess, appendicitis or peritonitis Other adverse events related to the biopsy procedure (abdominal pain, cramps) Patient discomfort | — |
Countries
Netherlands