ColoReg: A Register for Gastrointestinal Endoscopy Reports and Examination Videos

NCT06920680 | Recruiting

• 1 other identifier: 151/23-sc
• Study Type: observational
• Target: 1,834
• Locations: 1 country
• Sites: 2

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 Teaching materials for this purpose are scarcely available, often outdated (especially images), and usually show obvious cases.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. 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. 2.Achieve successful retrieval of polyps in more than 95% of cases.
3. 3.Document minor bleedings, defined as continuous bleeding for over 30 seconds that requires clipping.

Conditions

Colorectal Cancer; Colonoscopy; Polypectomy

Keywords

colorectal cancer; colonoscopy; standardized documentation; interventional endoscopy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Intervention time by method of removal (>= 20 mm)

  through study completion, an average of 1 year

• Rate of unforeseen re-examination within 3 months after polypectomie (lesions >= 20 mm)

  through study completion, an average of 1 year

Study Arms (1)

Colonoscopy

All patients recruited in a study center are included.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with planned diagnostic or therapeutic colonoscopy.

You may qualify if:

• Indication for diagnostic or therapeutic colonoscopy

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• Krankenhaus Barmherzige Brüder, Regensburg: collaborator
• Robert Bosch Medical Center: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Klinikum Ludwigsburg: collaborator

Study Sites (2)

Robert Bosch Krankenhaus

Stuttgart, Baden-Wurttemberg, 70376, Germany

RECRUITING

University Hospital Würzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Alexander Meining, Prof.

  University Hospital Wuerzburg

  STUDY CHAIR

Central Study Contacts

Thomas J. Lux, Dr. med. M. Sc.

CONTACT

+49 931 201 40247; lux_t1@ukw.de

Yvonne Josef

CONTACT

+49 931 201 40255; josef_y@ukw.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: April 10, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• 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.
• Access Criteria: Due to the experimental nature of this plan no specific access criteria are available yet.

Locations

DE (2)