Assessment of Endoscopic Tip Control Using a Novel Score Based on Snare Tip Soft Coagulation of ex Vivo Model (HAM STUDY)
Introduction: Colorectal cancer (CRC) is a significant global health concern, with colonoscopy being the primary screening tool for its detection and treatment. Endoscopic techniques such as snare tip soft coagulation (STSC) play a crucial role in reducing adenoma recurrence post-resection. However, assessing endoscopists' proficiency in tip control during these procedures remains challenging. This study aims to develop and validate a web-based scoring system to objectively evaluate endoscopist tip control during STSC application.
Research Questions:
- Can STSC application on an ex vivo model effectively measure endoscopic tip control across different levels of endoscopists' experience?
- Is there a correlation between tip control and endoscopists' polypectomy experience?
- Does tip control vary based on endoscopists' specialization?
- Can training on the STSC model improve endoscopists' tip control?
- Is it feasible to train an AI model using videos scored by expert raters to assess tip control?
- Can tip control be used as an objective measure to predict endoscopists' future performance?
Research Hypothesis: The investigators hypothesize that developing a model for easy tip control assessment will enable endoscopists to evaluate their proficiency and track progress. Training on the STSC model will enhance tip control, and cut-offs for tip control derived from preliminary data will be refined through this study.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Study Endpoints: Primary endpoints include correlating STSC accuracy and speed with endoscopist expertise profiles, defining expected tip control ranges, and assessing agreement between raters. Secondary endpoints focus on evaluating improvement in tip control following training.
Methods: A prospective trial will be conducted, involving endoscopists of varying experience levels.
Participants will undergo assessments while performing STSC on the margin of a line within an ex vivo model to simulate a polypectomy defect. The assessments will be video-recorded and anonymized. After the first assessment, the participants will perform a tip control training session on the model before each subsequent assessment. A total of four assessments and three training sessions will be performed. An online application will be used by a pool of 6 expert raters to anonymously rate the videos of the STSC application and calculate the accuracy (number of correct hits over number of wrong hits) and the speed (hits/second) of tip control. No questionaries will be administered to the participants.
Statistical Methods: Statistical analysis will be performed using R software, with data collected and managed in Excel. Pseudonymized data will be stored securely on the hospital server.
Conclusion: This study outlines a comprehensive approach to evaluating endoscopist tip control during STSC application. By developing a standardized assessment tool and conducting a prospective trial, the investigators aim to improve our understanding of tip control proficiency and its implications for endoscopic practice.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Lynn Deleu
- Telefonnummer: +32 93321063
- E-post: lynn.deleu@uzgent.be
Studieorter
-
-
East-Flanders
-
Ghent, East-Flanders, Belgien, 9000
- Rekrytering
- UZ Ghent
-
Kontakt:
- Lynn Deleu
- Telefonnummer: +32 93321063
- E-post: lynn.deleu@uzgent.be
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Digestive endoscopists at any level of training (trainee, consultant endoscopist, or advanced/interventional endoscopist)
- Signed informed consent for study participation
Exclusion Criteria:
- No signed informed consent for study participation
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: STSC training
A free 3D-printed template with dye shapes is used to mark shapes on ham.
Endoscopists will then use a snare through the endoscope channel to trace blue-dyed lines with electrosurgical precision.
|
Exposure to the HAM model during self-directed learning.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Speed and accuracy of STSC
Tidsram: From baseline STSC assessment (T1) through the final post-training STSC assessment (T4), assessed up to 4 weeks per participant.
|
To check the correlation of the accuracy and speed of STSC with the endoscopist's experience profile, the shape of the figure to which STSC is applied and the endoscopist's specialization. The definition of the expected range of tip control speed and accuracy for the different types of endoscopists. The definition for the cut-offs for extraordinary and poor tip control. An agreement in the STSC score between different reviewers. |
From baseline STSC assessment (T1) through the final post-training STSC assessment (T4), assessed up to 4 weeks per participant.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- ONZ-2024-0214
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .