ColoReg: A Register for Gastrointestinal Endoscopy Reports and Examination Videos

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 Teaching materials for this purpose are scarcely available, often outdated (especially images), and usually show obvious cases.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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Colonoscopy; Polypectomy

• Study Type: Observational
• Enrollment (Estimated): 1834

Contacts and Locations

• Study Contact: Name: Thomas J. Lux, Dr. med. M. Sc.; Phone Number: +49 931 201 40247; Email: lux_t1@ukw.de
• Study Contact Backup: Name: Yvonne Josef; Phone Number: +49 931 201 40255; Email: josef_y@ukw.de

Study Locations

• Germany
  • Baden-Wurttemberg
    • Stuttgart, Baden-Wurttemberg, Germany, 70376
      • Recruiting
      • Robert Bosch Krankenhaus
      • Contact: Martin Schich, Dr. med; Phone Number: +49 711 8101-0; Email: martin.schich@rbk.de
      • Principal Investigator: Martin Schich, Dr. med
  • Bavaria
    • Würzburg, Bavaria, Germany, 97080
      • Recruiting
      • University Hospital Wurzburg
      • Contact: Thomas J. Lux, Dr. med. M. Sc.; Phone Number: +49931-201-40247; Email: lux_t1@ukw.de
      • Contact: Yvonne Josef; Phone Number: +49931-201-40255; Email: josef_y@ukw.de
      • Principal Investigator: Thomas J. Lux, Dr. med. M. Sc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with planned diagnostic or therapeutic colonoscopy.

Description

Inclusion Criteria:

• Indication for diagnostic or therapeutic colonoscopy

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Colonoscopy; All patients recruited in a study center are included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0 Resection Rate by Removal Method (lesion size >= 20 mm)	Rate of histologically complete resection for removed pre-cancerous and cancerous lesions >= 20 mm.	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	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.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention time by method of removal (>= 20 mm)	Time required from discovery of a polyp to completed treatment including handling of immediate complications.	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)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Collaborators: Klinikum Ludwigsburg; Universitätsklinikum Hamburg-Eppendorf; Robert Bosch Medical Center; Krankenhaus Barmherzige Brüder, Regensburg
• Investigators: Study Chair: Alexander Meining, Prof., University Hospital Wuerzburg

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 8, 2024
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: colorectal cancer; colonoscopy; standardized documentation; interventional endoscopy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 151/23-sc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized images from endoscopy examination videos may be published on an research / educational platform.
• IPD Sharing Time Frame: Study Protocol and ICF will be available at study start. Analytic code will be published after completion of analyses. Individually selected images or video sequences may be anonymously used on a online platform. Due to the experimental nature of this plan no specific time frame is available yet.
• IPD Sharing Access Criteria: Due to the experimental nature of this plan no specific access criteria are available yet.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No