Colo-rectal Cancer Clinical Trial
— GPATOfficial title:
Validation of the Global Polypectomy Assessment Tool (GPAT) - a Novel Online Assessment Tool for Any Colorectal Polypectomy
Verified date | June 2024 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Colorectal polypectomy is offten incompletely performed with high variability between endoscopists, resulting in interval cancer or repeated procedures. Current available scoring systems for polypectomy technique are lacking in different areas so the investigators developed the Global Polypectomy Assessment Tool (GPAT) which is an online video-based assessment tool for any colorectal polypectomy. The goal of the study is to assess the validity of GPAT through demonstrating the inter-rater agreement (Fleiss Kappa (κ)). GPAT has 20 items, contains evidence-based statements to aid interpretation, calculates an overall quality score and a complexity score.
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | March 2, 2027 |
Est. primary completion date | March 1, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Endoscopists of varying abilities and grades - Adult patients undergoing a polypectomy who agree to participate Exclusion Criteria: - Endoscopist does not consent to inclusion - Patient does not consent to inclusion - Patients <18 y |
Country | Name | City | State |
---|---|---|---|
Belgium | uz Gent | Ghent | Gent |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To validate the GPAT (global polypectomy assesment tool) scoring tool for polypectomy using key performance indicators. | Two scores are generated by this tool. The first score provides an indication on the quality of the polypectomy. This comprises of 6 domains: global competencies, injection, snare placement, safety checks, defect assessment, accessory techniques. The second score gives an indication on the difficulty of the polypectomy based upon the difference between the complexity of the assessed procedure and the maximum possible complexity (Size, morphology, site, access and 4 plus criteria: Size > 40mm, non granular morfology, non lifting polyp/previously attempted, ileocaecal valve, diverticular or appendiceal orifice involvement). If some categories or questions are not relevant, it does not affect the score. The number of questions per category differs as well as the possible answers for each question. The score-system is web-based.
The maximum score for the first part of the tool is 105. For the indication on the difficulty of the polypectomy the maximum score is 17. |
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