Colorectal Polyp
Conditions
Brief summary
This two parallel arms, randomized, multicenter trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of adenoma detection. Secondary aims will be advanced adenoma detection rate, serrated polyp/adenoma detection rate, as well as procedure variables such as withdrawal time.
Interventions
DIAGNOSTIC_TESTTXI Light Imaging
Standard Colonoscopy using TXI imaging
DIAGNOSTIC_TESTWLI Imaging
Standard Colonoscopy using White Light Imaging
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- All \>40 years-old patients undergoing a colonoscopy for primary screening, Faecal Immunochemical Test (FIT) +, post-polypectomy surveillance
Exclusion criteria
* patients with personal history of colorectal cancer (CRC), or Inflammatory Bowel Disease (IBD). * Patients affected with Lynch syndrome or Familiar Adenomatous Polyposis. * patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment). * patients with previous colonic resection. * patients on antithrombotic therapy, precluding polyp resection. * patients who were not able or refused to give informed written consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Detection Rate (ADR) | 1 year | the proportion of participants with at least one adenoma (per-patient analysis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Advanced ADR | 1 year | as the proportion of participants with at least one advanced adenoma at a per-patient analysis |
| polyps, adenomas, advanced adenomas and Sessile Serrated Polyps (SSP) per subject | 1 year | the total number of detected lesions in each group divided by the total number of participants (per polyp analysis) |
| proximal and flat adenomas detection rate | 1 year | the total number of detected lesions in each group divided by the total number of participants (per-polyp analysis) |
| Withdrawal time | 1 year | Time from the start of the inspection at the cecum and the withdrawal of the colonoscope from the body of the patient. |
Countries
Italy
Outcome results
None listed