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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Lynn Deleu
- 電話番号：+32 93321063
- メール：lynn.deleu@uzgent.be
研究場所
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East-Flanders
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Ghent、East-Flanders、ベルギー、9000
- 募集
- UZ Ghent
-
コンタクト：
- Lynn Deleu
- 電話番号：+32 93321063
- メール：lynn.deleu@uzgent.be
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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Exposure to the HAM model during self-directed learning.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Speed and accuracy of STSC
時間枠：From baseline STSC assessment (T1) through the final post-training STSC assessment (T4), assessed up to 4 weeks per participant.
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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.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- ONZ-2024-0214
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。