Clinical trial NCT06920680: ColoReg: A Register for Gastrointestinal Endoscopy Reports and Examination Videos
Official title: ColoReg: A Register for Gastrointestinal Endoscopy Reports and Examination Videos
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Colonoscopy
Polypectomy
Keywords: colorectal cancer
colonoscopy
standardized documentation
interventional endoscopy
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: Robert Bosch Medical Center
name: Krankenhaus Barmherzige Brüder, Regensburg
name: Universitätsklinikum Hamburg-Eppendorf
name: Klinikum Ludwigsburg
First posted: 2025-04-10
Enrollment: 1834
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with planned diagnostic or therapeutic colonoscopy.

Brief 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 Teaching materials for this purpose are scarcely available, often outdated (especially images), and usually show obvious cases.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.


Eligibility criteria: Inclusion Criteria:

* Indication for diagnostic or therapeutic colonoscopy

Exclusion Criteria:

-

Primary outcomes:
measure: R0 Resection Rate by Removal Method (lesion size >= 20 mm)
timeFrame: through study completion, an average of 1 year
measure: Inconspicious follow-up by method of Removal (lesion >= 20 mm)
timeFrame: through study completion, an average of 1 year
measure: Major Complication Rate (lesion size >= 20 mm)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Intervention time by method of removal (>= 20 mm)
timeFrame: through study completion, an average of 1 year
measure: Rate of unforeseen re-examination within 3 months after polypectomie (lesions >= 20 mm)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: University Hospital Würzburg
state: Bavaria
Study officials:
affiliation: University Hospital Wuerzburg
name: Alexander Meining, Prof.
role: STUDY_CHAIR
References: