An observational study in Colorectal Cancer, Colonoscopy and Polypectomy, sponsored by Wuerzburg University Hospital. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Wuerzburg University Hospital · Observational
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 Teaching materials for this purpose are scarcely available, often outdated (especially images), and usually show obvious cases.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:
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.
5,600 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 1,834 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Wuerzburg University Hospital is the lead sponsor of 96 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with planned diagnostic or therapeutic colonoscopy.
Exclusion Criteria:
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All patients recruited in a study center are included.
R0 Resection Rate by Removal Method (lesion size >= 20 mm)
Rate of histologically complete resection for removed pre-cancerous and cancerous lesions \>= 20 mm.
Time frame: through study completion, an average of 1 year
Inconspicious follow-up by method of Removal (lesion >= 20 mm)
Rate of macroscopically endoscopic follow-up examinations within 1 year if performed
Time frame: through study completion, an average of 1 year
Major Complication Rate (lesion size >= 20 mm)
Rate of examination related major complications defined as endoscopically uncontrollable bleedings or perforations.
Time frame: through study completion, an average of 1 year
Intervention time by method of removal (>= 20 mm)
Time required from discovery of a polyp to completed treatment including handling of immediate complications.
Time frame: through study completion, an average of 1 year
Rate of unforeseen re-examination within 3 months after polypectomie (lesions >= 20 mm)
Rate of unforeseen re-examination within 3 months after polypectomie (lesions \>= 20 mm)
Time frame: through study completion, an average of 1 year
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Anonymized images from endoscopy examination videos may be published on an research / educational platform.
Supporting information: Study protocol, Icf, Analytic code
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Wuerzburg University Hospital