ColoReg: A Register for Gastrointestinal Endoscopy Reports and Examination Videos

Summary

With the participants help, the investigators aim to track treatment methods, treatment outcomes, and adverse events, as well as document the treatment strategies used during endoscopic colorectal cancer prevention and treatment. This will allow us to verify if the results from targeted clinical studies and current scientific knowledge are also reflected in the real world. Additionally, the investigators want to use the collected videos and findings to support the training of doctors. During each examination, doctors must be able to accurately assess the inside of the body. Teaching materials for this purpose are scarcely available, often outdated (especially images), and usually show obvious cases. The investigators aim to provide doctors with the opportunity to learn outside of real patient examinations and benefit from the experiences of others.

Furthermore, the investigators want to make the findings and video data accessible to the scientific community. Since scientific studies rarely publish raw data for this purpose, there is currently no large and constantly updated database of findings, images, and videos. If a study requires such data, new data must be collected with great organizational and financial effort. As a result, different studies are only partially comparable, and their significance is reduced.

By publishing the data, a valuable information source for medical professionals in training, continuing education, and advanced training is created. Researchers also benefit from this data: New technologies, such as image analysis software, can be tested and compared on a consistent basis. Therefore, participation in this study makes a valuable contribution to the foundation of good medical care: education, research, and quality assurance.

Primary Study Goal:

The study aims to evaluate the effectiveness and safety of different endoscopic resection techniques. Effectiveness is defined as achieving a complete removal of the lesion (R0 resection) or having a clear follow-up in more than 90% of cases. Safety is defined as having less than 3% of cases result in complications like perforation, uncontrollable bleeding, or the need for unplanned follow-up due to issues like interval bleeding or perforation. The target diagnostic accuracy is 95%.

Secondary Study Goals:

1. Ensure that in 90% of cases, the recommended follow-up interval aligns with current national guidelines based on the number, size, and histopathology of polyps.
2. Achieve successful retrieval of polyps in more than 95% of cases.
3. Document minor bleedings, defined as continuous bleeding for over 30 seconds that requires clipping.

Tertiary Study Goal:

Develop software that can identify and mask sensitive information (such as names, birth dates, examination dates, and video sections outside the human body) in videos from 1,000 examinations, or flag them for manual review. Similarly, the software should identify and remove sensitive text information in the reports, such as names, birth dates, case numbers, examiners, and phone numbers, or mark the text for manual review.

Conditions

• Colorectal Cancer
• Colonoscopy
• Polypectomy

Sponsors & Collaborators

• Robert Bosch Medical Center

  collaborator OTHER

• Krankenhaus Barmherzige Brüder, Regensburg

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• Klinikum Ludwigsburg

  collaborator OTHER

• Wuerzburg University Hospital

  lead OTHER

Principal Investigators

• Alexander Meining, Prof. · University Hospital Wuerzburg

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2026-10-31

Completion

2027-10-31

Countries

• Germany

Study Locations