Идёт набор NCT07609017

Assessment of Endoscopic Tip Control Using a Novel Score Based on Snare Tip Soft Coagulation of ex Vivo Model (HAM STUDY)

Без фазы С лечением Evaluating Endoscopist Tip Control During STSC Application

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Ham-based Assessment Model.
Кому может быть актуально: Состояния в реестре: Evaluating Endoscopist Tip Control During STSC Application. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бельгия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Процедура Ham-based Assessment Model
Exposure to the HAM model during self-directed learning.

Первичные конечные точки

Speed and accuracy of STSC [Срок оценки: From baseline STSC assessment (T1) through the final post-training STSC assessment (T4), assessed up to 4 weeks per participant.]

Критерии участия

Критерии включения

Digestive endoscopists at any level of training (trainee, consultant endoscopist, or advanced/interventional endoscopist)
Signed informed consent for study participation