Lynch syndrom polyps
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Diagnosis of Lynch-syndrome, with a germline mutation in one of the MMR genes (MLH1, MSH2, MSH6) or deletions in the 3* region of the EpCAM gene - Age >18 years - Surveillance colonoscopy for Lynch syndrome.
Exclusion criteria
Exclusion criteria: - Recent surveillance colonoscopy within 1 year from current exam (e.g. after piecemeal EMR) or patients referred for endoscopic evaluation of known colorectal neoplasia. - Colonoscopy planned for the evaluation of symptoms like rectal blood loss, recent change in bowel habits, weight loss or anemia. - Patients with a concurrent diagnosis of (serrated) polyposis syndrome or inflammatory bowel disease. - Patients who are unwilling or unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adenoma detection rate of colonoscopy with CADe system versus colonoscopy without CADe system | — |
Secondary
| Measure | Time frame |
|---|---|
| - The difference in polyp detection rate between colonoscopy with and without CADe system - The difference in mean number of polyps between colonoscopy with and without CADe system - The difference in mean number of adenomas between colonoscopy with and without CADe system - The difference in mean number of serrated polyps between colonoscopy with and without CADe system - The difference in proximal serrated polyp detection rate between colonoscopy with and without CADe system - The difference in mean number of proximal serrated polyps between colonoscopy with and without CADe system - The mean duration of both endoscopic procedures with and without CADe system: time for inspection and time for performing endoscopic resection - False positive detections of the CADe system: a flashing alert (whereby a detection box, circle and/or sound signal appears then disappears) and consistent false detection (whereby the CADe system consistently identifies a non-polyp structure as a polyp but the endoscopist disagrees at close observation) | — |
Countries
Netherlands