Enhancing Endoscopic Scoring Consistency and Accuracy in IBD: a Video-based Training Approach

NCT06961942 | Not Yet Recruiting

• 1 other identifier: CONCORDIA
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Endoscopic scoring systems are vital for the objective assessment of disease activity being used in both clinical trials and daily clinical practice. These standardized scoring systems are essential for diagnosing, evaluating endoscopic healing, monitoring treatment response, and predicting clinical outcomes. One of the primary challenges in implementing these scoring systems is inter-observer variability, as highlighted by significant discrepancies between scores assigned by local and central reviewers. However, the performance of these systems among experts has been shown to be excellent, suggesting that achieving consistent and accurate scoring requires a high level of exposure and proficiency. Inconsistent scoring, especially among less experienced clinicians, poses a challenge to the reliability of these scoring systems. The primary objective of this study is to evaluate the improvement of scoring accuracy after training with structured educational videos with a specific focus on the learning curve and the practical application of endoscopic scoring systems.

Conditions

IBD (Inflammatory Bowel Disease)

Keywords

Training; Scoring; IBD

Outcome Measures

Primary Outcomes (3)

• Improvement of Updated Rutgeerts scoring accuracy after training with structured educational videos

  In substudy A, the investigators will focus on the updated Rutgeerts score for patients with Crohn's disease that previously underwent an ileocolonic resection with ileocolonic anastomosis.

  3 months

• Improvement of ePDAI scoring accuracy after training with structured educational videos

  In substudy B, the investigators will focus on the Endoscopic element of the Pouchitis Disease Activity Index (ePDAI) for patients with ulcerative colitis that previously underwent a proctocolectomy with ileal pouch-anal anastomosis (IPAA). ePDAI consists of six features describing mucosal changes: oedema, granularity, friability, loss of vascular pattern, mucous exudate and ulceration.

  3 months

• IImprovement of SES-pouchitis scoring accuracy after training with structured educational videos

  In substudy B, the investigators will focus on the Simple Endoscopic Score (SES)-pouchitis for patients with ulcerative colitis that previously underwent a proctocolectomy with ileal pouch-anal anastomosis (IPAA). SES-pouchitis evaluates four key parameters, ulcer size, ulcerated surface, affected surface area, and luminal narrowing, in the ileal pouch.

  3 months

Study Arms (2)

Group A (Early training)

ACTIVE COMPARATOR

Following the first video assessment only participants in Group A will attend the structured training module. During Time Period 2 (approximately one month), all participants will score the same 15 + 15 videos. However, only participant in Group A will have access to the explanatory videos used in the online training module.

Other: Training

Group B (Late training)

NO INTERVENTION

After the second video assessment participants in Group B will receive the structured training module. During Time Period 3 (approximately one month), participants in Group B will score the 15 + 15 videos again while having access to the explanatory videos used in the online training module.

Interventions

Training OTHER

A structured teaching module for fellows in training will be prepared and conducted at three university centres, namely University Hospitals Leuven, Ljubljana University Medical Centre, and CHU de Bordeaux. The training module will include short endoscopic videos (different from the pre- and post-training set), which participants will score in real-time using a polling application. This will be followed by a step-by-step demonstration of each scoring principle with explanations of the reasoning behind specific scores. Each scoring system will be reviewed in a short training video that provides a structured demonstration, highlights common pitfalls, and showcases typical IBD-associated endoscopic features. After the video training, participants will have the opportunity to ask questions to the experts.

Group A (Early training)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gastroenterology fellows

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Marc Ferrante

CONTACT

+3216344225; marc.ferrante@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The CONCORDIA study will be conducted in three sequential time periods. During Time Period 1 (two months), all participants will independently score 15 endoscopic videos using the updated Rutgeerts score and 15 videos with ePDAI and SES-pouch, supplemented with a general Visual Analogue Scale (VAS) score (0=no inflammation, 10=most severe inflammation). No specific guidance will be provided during that phase. Following the first video assessment only participants in Group A will attend the structured training module. During Time Period 2 (one month), all participants will score the same 15 + 15 videos. However, only participant in Group A will have access to the explanatory videos used in the online training module. After the second video assessment participants in Group B will receive the structured training module. During Time Period 3 (one months), participants in Group B will score the 15 + 15 videos again while having access to the explanatory videos used in the online training.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 8, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share