ColoReg: A Register for Gastrointestinal Endoscopy Reports and Examination Videos
Conditions: Colorectal Cancer, Colonoscopy, Polypectomy
Sponsor: Wuerzburg University Hospital

 
 
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Study: ColoReg 
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1. Title 
Name of the study: ColoReg: A register for findings and videos of endoscopies in 
gastroenterology 
Name of the study (English): ColoReg: A Register for Gastrointestinal Endoscopy 
Reports and Examination Videos 
Short name (if applicable): ColoReg 
Version number of the protocol: 0.4_RBK 
Date of the minutes: 10.03.2024 
2. Responsibilities 
Study director: Dr. med. Thomas J. Lux 
Institution: Medical Clinic II, University Hospital Würzburg 
Participating institutions and departments: 
Gastroenterology, Medical Clinic II, University Hospital Würzburg 
3. Signatures to confirm the minutes 
 
Clinic director or head of an institute (if not study director): 
 
_________________________  
 
 
_________________________ 
Place, date  
 
 
 
 
 
Prof. Dr. Hermann Einsele 
 
Head of Gastroenterology: 
 
_________________________  
 
 
_________________________ 
Place, date  
 
 
 
 
 
Prof. Dr. Alexander  
 
 

 
 
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Director of Studies: 
 
_________________________  
 
 
_________________________ 
Place, date  
 
 
 
 
 
Dr. Thomas J. Lux  
 
4. Rationale 
Background 
Endoscopic procedures such as gastroscopies and colonoscopies are a fundamental 
part of diagnostics and treatment in gastroenterology. Gastroscopy can reliably identify 
or rule out serious causes of abdominal pain and colonoscopy is used worldwide as 
part of colorectal cancer screening. Endoscopic procedures can be used 
therapeutically to treat pathological changes, e.g. precancerous lesions or cancer, 
curatively or in a symptom-oriented manner. 
Technical and scientific progress 
The options available for gastroenterological endoscopy are constantly increasing. 
Improvements in camera systems have increased the resolution and color depth of 
videos. In addition, digital post-processing of the image signal or changes to the light 
source ("narrow band imaging") have developed alternatives to previously used color 
solutions.  
Significant progress has also been made in the field of therapy. While benign, larger 
polyps were still primarily removed surgically in the 2000s, early forms of stomach and 
bowel cancer are now also primarily removed endoscopically.  
Clinical studies vs. real world data 
As pleasing as the rapid progress in the field of endoscopy is, this progress also brings 
with it problems. Prospective clinical studies naturally require a high degree of planning 
and, in particular, only reflect the application in non-academic centers to a limited 
extent. As the conduct of a clinical trial itself can have a significant effect on treatment, 
findings should always be checked against "real world" data. For example, a study by 
Vavricka et al.1 showed that third parties the proportion of colonoscopies for screening 
 
1 Vavricka, S. R., Sulz, M. C., Degen, L., Rechner, R., Manz, M., Biedermann, L., Beglinger, C., Peter, 
S., Safroneeva, E., Rogler, G., & Schoepfer, A. M. (2016). Monitoring colonoscopy withdrawal time 

 
 
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with detected precancerous lesions from 21% to 36% after the examiners were 
informed that the duration of the procedure would be measured.  
Training and further education 
As described above, the images seen during an endoscopy and the therapies carried 
out are subject to constant change. New aspects of the findings - both of healthy and 
pathological origin - become visible through higher image quality. Large quantities of 
normal and pathological findings are required to train good endoscopists.  
Few illustrative materials (e.g. individual video clips) are available, particularly for novel 
therapies. 
State of research 
To our knowledge, there is no comprehensive register for the processing of video and 
diagnostic texts of clinical endoscopies, neither in Germany nor internationally. 
Justification of the study to be carried out 
The need for structured and standardized recording of findings and interventions in 
gastroenterological endoscopy is evident. The planned study aims to record the 
structuring of the findings and compare them with current recommendations for 
reporting. This will continuously monitor the objectivity and reproducibility of the 
findings and enable us to identify discrepancies between theory and practice. In 
addition, the study will comprehensively record the interventions performed, including 
the indication, the technique used, possible immediate complications and the macro- 
and microscopic outcome. This is particularly relevant in the context of the application 
of novel forms of therapy. 
Another key element of the study is the creation of a database for diagnostic images 
and video clips of interventions performed. These databases will not only advance 
research in the field of endoscopy, but will also provide valuable resources for the 
education and training of specialists. In addition, the publication of the established 
databases will make an important contribution to the validation of the increasing 
number of AI applications in the field of endoscopy. By providing a comprehensive and 
high-quality database, AI models can be trained more efficiently and their performance 
can be better evaluated. This is particularly important in light of the rapid technological 
developments and the increasing integration of AI into clinical practice. 
 
significantly improves the adenoma detection rate and the performance of endoscopists. Endoscopy, 
48(3), 256-262. https://doi.org/10.1055/s-0035-1569674 

 
 
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Risk-benefit assessment 
The ethical dimension of the study requires careful consideration of the risks and 
benefits. The primary risk of the study lies in the handling of personal data. To minimize 
this risk, all data will be de-identified before being transferred to the registry. In addition, 
the study participants are informed in detail about the type of data collection, de-
identification, further processing and publication. This procedure ensures that the 
privacy of the participants is protected and ethical standards are adhered to. 
In contrast to this is the considerable benefit of the study for clinical application, 
research and training. The systematic recording and structuring of findings and 
interventions will improve the quality of medical care and advance research in the field 
of gastroenterological endoscopy. In addition, the databases created will provide 
valuable resources for the education and training of specialists and enable the 
validation of AI applications. Against this backdrop, the risk can be considered minimal, 
particularly due to the data security precautions taken, while the potential benefits of 
the study are far-reaching and of great importance. 
 
 

 
 
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5. Study objectives 
 
The primary objective of this registry study is to systematically record and analyze the 
efficacy and safety of various endoscopic procedures used to prevent and treat 
colorectal cancer and its precursors. In addition, relevant image material is to be 
selected so that it can be used for training purposes and further research projects. 
 
The secondary objectives include the evaluation of the quality of findings and treatment 
in the context of the current guidelines. For example, questions such as: "How often 
was the follow-up interval selected in accordance with the guidelines? And if this was 
deviated from, can this be justified by the documentation of the findings?" 
 
The tertiary goal of the study is to increasingly automate the process of data extraction 
and processing. Subsequently, the developed system is to be propagated to non-
academically interested treatment centers in order to establish a nationwide, possibly 
international, register. 
 
For patients themselves, there is no direct benefit from participating in the study. The 
benefit to society lies on the one hand in the rapid assessment of the success and 
benefits of the methods used under "real world" conditions, and on the other hand in 
the promotion of research and training. 
 
Primary study objective 
 
The following parameters define an endoscopic ablation technique: 
- 
Technology used 
o En bloc ablation vs. fractional ablation 
o + / - Injection 
o Technology:  
▪ Endoscopic mucosal resection (EMR) 
▪ Endoscopic submucosal dissection (ESD)  
▪ Endoscopic full-thickness wall resection (EFTR) 

 
 
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- 
Instrument used 
o Cold sling 
o Diathermy loop (incl. current setting used 
In our study, an endoscopic technique is defined as effective if one of the following 
results was achieved in more than 90% of the applications: 
- 
Histologically confirmed R0 ablation 
- 
Inconspicuous follow-up examination 
 
In our study, an endoscopic technique is defined as safe if at least one of the following 
events occurs in less than 3% of applications: 
- 
Perforation 
- 
Endoscopically uncontrollable bleeding 
- 
Need for an unplanned follow-up examination with evidence of interval bleeding 
or perforation 
- 
Detection of a stenosis with impassable lumen narrowing in a follow-up 
examination 
 
The target diagnostic reliability is 95 %. 
 
Secondary study objectives 
 
- 
The recommended follow-up interval depending on polyp number, size and 
histopathology should correspond to the current national guideline at the time 
of the examination in 90% of examinations. 
- 
Polyps recovered in > 95% of cases 
- 
Minor bleedings (defined as continuous bleeding > 30 seconds with subsequent 
clip supply) 
 
Tertiary study goal 
 

 
 
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Video processing: The software should identify and mask the sensitive information 
contained in 100% of 1,000 examinations (name, date of birth, date of examination, 
video sections outside the human body) or mark the video as "to be processed 
manually". 
 
Text processing: The software should recognize and remove the sensitive information 
contained in 100% of 1,000 examinations (names, date of birth, case numbers, 
examiners, telephone numbers) or mark the text as "to be edited manually". 
 
6. Study design 
 
This study is a prospective registry study in which data is collected from patients 
undergoing endoscopic examination for diagnosis or treatment.  
Included patients will be followed up for at least 3 (no recommendation for follow-up 
within one year) but not more than 12 months before anonymization and transfer of 
data. 
 
7. Study population 
 
The study population includes patients undergoing endoscopic examination for 
diagnostic or therapeutic purposes. Study participants are recruited as part of their 
treatment at the participating center. 
 
Patients are eligible to participate if they fulfill the following inclusion criteria: 
- 
Age of at least 18 years 
- 
Ability to provide information and consent 
- 
Indication for an endoscopic examination 
 
Patients are excluded if they fulfill at least one of the following exclusion criteria: 

 
 
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- 
Inability to perform the planned endoscopic examination for medical reasons 
 
 

 
 
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8. Individual study program 
Place of the intended investigations & processing of personal data: 
 
Robert Bosch Hospital 
Auerbachstrasse 110 
70376 Stuttgart 
 
A list of all participating trial centers can be found in the patient information 
 
Place of processing anonymized data records: 
 
University Hospital Würzburg 
Medical Clinic and Polyclinic II, Gastroenterology 
Oberdürrbacher Str. 6 
97080 Würzburg 
 
Information and consent 
 
The indication for an endoscopy is given by an internal medicine doctor. The patient is 
informed about the procedure and risks in writing using the information sheets used in 
everyday clinical practice. 
 
After checking the inclusion and exclusion criteria, a member of staff from the 
Department of Internal Medicine II will provide information about the study at the 
earliest possible time, on the day the indication is established. 
 
 
 

 
 
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Study dates / timetable 
Unscheduled re-endoscopies related to the primary examination within 3 months and 
scheduled follow-up appointments within one year are included. There are no 
additional appointments within the study. 
 
Measures 
As part of the endoscopic examination, the video signal during the examination and 
the full text of the findings with associated histology are recorded in de-identified form. 
In the case of ablation using a diathermy snare, the device setting used (current curve) 
should also be recorded. 
 
9. Adverse events 
Not applicable. 
 
 

 
 
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10. Biometric aspects 
Our study is intended to record the endoscopic procedures currently used, the quality 
of the current findings and videos of the corresponding examinations in various 
centers. The anonymized data collected will be published and used for further research 
and teaching. The feasibility and usefulness of the study should be examined on the 
basis of the above-mentioned study objectives. The following data will be collected for 
this purpose: 
 
The planned exploratory comparisons, such as subgroup comparisons, are not of a 
confirmatory nature. The reasons for this are the high variance in the literature data, 
the fluctuating methodology of the underlying sources and the number of patients 
required. 
 
Primary study objectives 
1. Primary successful endoscopic ablation 
Objective: To estimate the rate of primary successful endoscopic ablation of polyps ≥ 
20 mm for the EMR and ESD techniques. 
Measure: Percentage success rate with 95% confidence interval for each technique. 
Exploratory analysis: Odds ratio for primary successful ablation (ESD vs. EMR) and 
subgroup comparisons: 
        - EMR en bloc vs. EMR fractionated vs. ESD 
        - Influence of the diathermy setting. 
 
2. R0 Resection rate 
Objective: To estimate the R0 resection rate for polyps ≥ 20 mm for EMR and ESD. 
Measure: Percentage R0 resection rate with 95% confidence interval for each 
technique. 
Exploratory analysis: odds ratio for R0 resection (ESD vs. EMR) and subgroup 
comparisons: 

 
 
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        - EMR en bloc vs. EMR fractionated vs. ESD 
        - Influence of the diathermy setting. 
 
3. Inconspicuous follow-up 
Objective: To estimate the rate of inconspicuous follow-up examinations for polyps ≥ 
20 mm after EMR and ESD. 
Measure: Percentage rate of inconspicuous follow-up with 95% confidence interval for 
each technique. 
Exploratory analysis: Odds ratio for inconspicuous follow-up (ESD vs. EMR) and 
subgroup comparisons: 
        - EMR en bloc vs. EMR fractionated vs. ESD 
        - Influence of the diathermy setting. 
 
    4.  (u. 5) Major complication rate 
Objective: To estimate the rate of major complications (endoscopically uncontrollable 
bleeding or perforation) in polyps ≥ 20 mm for EMR and ESD. 
Measure: Percentage rate of major complications with 95% confidence interval for 
each technique. 
Exploratory analysis: odds ratio for major complications (ESD vs. EMR) and 
subgroup comparisons: 
        - EMR en bloc vs. EMR fractionated vs. ESD 
        - Influence of the diathermy setting. 
 
 
 
 

 
 
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Secondary study objectives 
1. Duration of treatment 
Objective: To estimate the average treatment duration for polyps ≥ 20 mm for EMR 
and ESD. 
 Measure: Mean and standard deviation of treatment duration (minutes) for each 
technique. 
 Explorative analysis: influence of subgroups: 
        - EMR en bloc vs. EMR fractionated vs. ESD 
        - Use of a cap (+/-) 
        - Influence of the diathermy setting. 
 
2. Unplanned re-intervention 
Objective: To estimate the rate of unplanned re-interventions within 3 months after 
EMR and ESD. 
Measure: Percentage rate of unplanned re-interventions with 95% confidence interval 
for each technique. 
Exploratory analysis: odds ratio for unplanned re-intervention (ESD vs. EMR) and 
subgroup comparisons: 
        - EMR en bloc vs. EMR fractionated vs. ESD 
        - Influence of the diathermy setting. 
 
 
 

 
 
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Case number estimation 
The case number estimation is based on the desired precision (width of the 95% 
confidence intervals) for the estimation of the event rates for the primary endpoints. 
Despite the purely descriptive nature of the primary endpoints, a Bonferroni correction 
is also applied to obtain precise estimates for EMR and ESD separately 
In the currently available literature, the success and complication rates for EMR and 
ESD vary greatly. In addition, much of the data is based on patients from academic 
centers. Therefore, the precise estimation of event rates in terms of our clinical 
endpoints provides highly relevant information for clinical and scientific purposes. 
Secondary, exploratory comparisons are made separately and are not of a 
confirmatory nature (odds ratio calculations, subgroups). 
Estimates from the literature 
The following event rates are estimated on the basis of the existing literature (clear 
meta-analysis: Hassan C, Repici A, Sharma P, et al., Gut 2016;65:806-820) and new 
results from a systematic search. Conservative assumptions were made for certain 
endpoints in order to calculate the number of cases: 
• Primary successful ablation: 
o EMR: 85% (95%-KI: 80% - 90%) 
o ESD: 95% (95%-KI: 93% - 97%) 
o  
• R0 resection: 
o EMR: 75% (95%-KI: 70% - 80%) 
o ESD: 90% (95%-KI: 87% - 93%) 
 
• Inconspicuous follow-up: 
o EMR: 86.2% (95%-KI: 85.3% - 87.1%) 
o ESD: 90% (estimated, based on similar studies). 
 
• Major complications (bleeding): 
o EMR: 3.6% (95%-KI: 2.9% - 4.3%) 
o ESD: 6.5% (95%-KI: 5.9% - 7.1%) 
 
 
• Major complications (perforations): 
o EMR: 1.95% (95%-KI: 1.5% - 2.4%) 
o ESD: 5.3% (95%-KI: 4.5% - 6.1%) 

 
 
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Calculation of the number of cases for primary endpoints with Bonferroni 
correction 
Adjustment of the significance level: 
• Original significance level: α=0.05 
• Number of primary endpoints: k=5 
• Adjusted significance level: αadj=α / k= 0.05= 0.01 
• The z-value for a 99% confidence interval (corresponding to αadj=0.01 is: z= 
2.576 
 
The number of cases is calculated using the adjusted formula: 
𝑛= 𝑧2  ⋅ 𝑝  ⋅ (1 −𝑝)
(𝐵𝑟𝑒𝑖𝑡𝑒 𝑑.  𝐾𝐼)2  
 
 
 

 
 
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Calculations 
1. major complications (bleeding): 
• EMR: p = 0.036, target width of the CI: ±1.5%. 
𝑛= 𝑧2  ⋅ 𝑝  ⋅ (1 −𝑝)
(𝐵𝑟𝑒𝑖𝑡𝑒 𝑑.  𝐾𝐼)2   =   2,5762  ⋅ 0,036  ⋅ (1 −0,036)
(0,015)2
  ≅ 411 
 
• ESD: p=0.065, target width of the CI: ±2%. 
𝑛= 𝑧2  ⋅ 𝑝  ⋅ (1 −𝑝)
(𝐵𝑟𝑒𝑖𝑡𝑒 𝑑.  𝐾𝐼)2   =   2,5762  ⋅ 0,065  ⋅ (1 −0,065)
(0,02)2
  ≅ 870 
 
2. major complications (perforations): 
• EMR: p=0.0195, target width of the CI: ±1% 
 
𝑛= 𝑧2  ⋅ 𝑝  ⋅ (1 −𝑝)
(𝐵𝑟𝑒𝑖𝑡𝑒 𝑑.  𝐾𝐼)2   =   2,5762  ⋅ 0,0195  ⋅ (1 −0,0195)
(0,01)2
  ≅ 128 
• ESD: p=0.053, target width of the CI: ±1.5% 
𝑛= 𝑧2  ⋅ 𝑝  ⋅ (1 −𝑝)
(𝐵𝑟𝑒𝑖𝑡𝑒 𝑑.  𝐾𝐼)2   =   2,5762  ⋅ 0,053  ⋅ (1 −0,053)
(0,015)2
  ≅ 289 
 
3. inconspicuous follow-up: 
• EMR: p=0.862, target width of the CI: ±3%. 
𝑛= 𝑧2  ⋅ 𝑝  ⋅ (1 −𝑝)
(𝐵𝑟𝑒𝑖𝑡𝑒 𝑑.  𝐾𝐼)2   =   2,5762  ⋅ 0,862  ⋅ (1 −0,862)
(0,03)2
  ≅ 666 
 
• ESD: p=0.90, target width of the CI: ±3%. 
 

 
 
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𝑛= 𝑧2  ⋅ 𝑝  ⋅ (1 −𝑝)
(𝐵𝑟𝑒𝑖𝑡𝑒 𝑑. 𝐾𝐼)2   =   2,5762  ⋅ 0,9  ⋅ (1 −0,9)
(0,03)2
  ≅ 692 
 
 
4. R0 resection rate: 
• EMR: p=0.75, target width of the CI: ±4%. 
𝑛= 𝑧2  ⋅ 𝑝  ⋅ (1 −𝑝)
(𝐵𝑟𝑒𝑖𝑡𝑒 𝑑.  𝐾𝐼)2   =   2,5762  ⋅ 0,75  ⋅ (1 −0,75)
(0,04)2
  ≅ 650 
 
• ESD: p=0.90, target width of the CI: ±3%. 
𝑛= 𝑧2  ⋅ 𝑝  ⋅ (1 −𝑝)
(𝐵𝑟𝑒𝑖𝑡𝑒 𝑑. 𝐾𝐼)2   =   2,5762  ⋅ 0,9  ⋅ (1 −0,9)
(0,03)2
  ≅ 692 
 
5. primary Successful ablation: 
• EMR: p=0.85, target width of the CI: ±3%. 
𝑛= 𝑧2  ⋅ 𝑝  ⋅ (1 −𝑝)
(𝐵𝑟𝑒𝑖𝑡𝑒 𝑑.  𝐾𝐼)2   =   2,5762  ⋅ 0,85  ⋅ (1 −0,85)
(0,03)2
  ≅ 785 
 
• ESD: p=0.95, target width of the CI: ±2%. 
𝑛= 𝑧2  ⋅ 𝑝  ⋅ (1 −𝑝)
(𝐵𝑟𝑒𝑖𝑡𝑒 𝑑.  𝐾𝐼)2   =   2,5762  ⋅ 0,95  ⋅ (1 −0,95)
(0,02)2
  ≅ 385 
 
Consideration of the endpoints with the highest number of cases 
For the most precise estimate of the endpoints, the highest case numbers after 
correction for multiple testing are used: 

 
 
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• EMR: Primary successful ablation: 785 patients. 
• ESD: Major complications (bleeding): 870 patients. 
 
Summary of case number planning 
• The aim is to precisely estimate the event rates taking into account the 
Bonferroni correction (αadj= 0.01)  
• Separate case numbers were calculated for EMR (785 patients) and ESD (870 
patients). 
• A total of 1,655 patients are required for both indications 
• In the sense of an observational colonoscopy registry, recruitment will continue 
until the number of cases for both indications has been reached 
 
 

 
 
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11. Data management 
Responsible for data processing: Dr. Thomas J. Lux 
Fundamentals 
Data protection is of the utmost importance for our study. All personal data collected 
as part of the study will be treated with the highest level of confidentiality and security. 
The data is collected in accordance with the General Data Protection Regulation 
(GDPR) and the principles of "privacy by default" and "privacy by design". Our aim is 
to protect the privacy of our study participants while collecting the necessary data to 
answer our research questions. 
The data protection and security concept was therefore an integral part of the project 
planning. No data is collected that goes beyond what is necessary for treatment and 
further care planning. Personal data is stored at the center of the medical treatment 
taking place on encrypted data carriers (digital data) and is stored in an access-
protected location (digital and analog data). 
At the end of the follow-up period, the data is de-identified at the treating center and 
the original data set is destroyed. Only data that has been anonymized in accordance 
with the patient information and the information sheet will be transferred to the study 
center (Würzburg) and included in the registry. 
In summary, it can be stated that participation in the study does not increase the 
number of people with access to personal data. 
Data collection, source data 
The video data is tapped directly at the endoscopy processor and stored 
pseudonymously on a computer in the treating clinic 
The texts of the examination findings and the histopathological findings are also stored 
pseudonymously on this computer. 
Data storage in the Participating Study Center 
The pseudonymized data is stored in encrypted form (Advanced Encryption Standard 
(AES), key length: 256-bit). 
Anonymization / pseudonymization 
In order to ensure the greatest possible data security at every stage of data processing, 
we use a multi-layered procedure. This includes the following steps: 

 
 
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- 
Ensuring anonymity of the video material (in particular: No patient data visible 
in the video; all video segments show only the inside of the body) 
- 
Ensuring anonymity of the findings texts (in particular: no remaining names, 
dates of birth, examination date in the text) 
- 
During the follow-up period, the data set contains a pseudonym as the only 
identifiable characteristic, which contains neither the patient's name nor date of 
birth 
- 
Before the data is transferred to the study center, it is irrevocably deleted 
 
The anonymized data set created for the register contains the following components: 
- 
Video from inside the body without names or dates of birth in the image  
- 
Findings texts without names and dates of birth in the text 
 
The anonymity of medical image material is an increasingly discussed topic. This 
discussion is based on the fact that - with the help of the original examination images 
- it is theoretically possible to trace the above-mentioned video back to the patient.  
In accordance with recital 26.32 of the GDPR, the means used for identification - in this 
case, access to the patient's medical data - should be taken into account. For persons 
with access to these specific medical data of the patient, there would be no gain in 
information by assigning the study data set. 
In addition, according to recital 26.43 of the GDPR, it should be determined how likely 
it is that appropriate means of identifying the person will be used, taking into account 
costs and time. Since the medical data is not for sale and the time required for 
identification would be considerable (attempt to find a specific video from a database 
using individual images), we finally refer to recital 26.54 and classify our data set as 
 
2To determine whether a natural person is identifiable, account should be taken of all the means likely to be used 
by the controller or another person to identify the natural person directly or indirectly, such as singling out.  
3 In determining whether means are reasonably likely to be used to identify the natural person, account should be 
taken of all objective factors, such as the cost of identification and the time required, taking into account the 
technology available at the time of processing and technological developments. 
4 The principles of data protection should therefore not apply to anonymous information, i.e. information that does 
not relate to an identified or identifiable natural person, or personal data that has been anonymized in such a way 
that the data subject cannot or can no longer be identified. 

 
 
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anonymized. The residual risk described here is also presented accordingly in the 
patient information and education. 
Data transmission and data storage at the study center 
The pseudonymized data is viewed and processed by employees of the treating 
specialist department.  
The anonymized data is viewed and processed by employees of the Department of 
Internal Medicine II at the University Hospital of Würzburg.  
In line with the study objective, the anonymized data will be made available to the 
public in whole or in part. This includes the cases mentioned in the patient information 
(online teaching and learning platform, video, image and findings data sets for further 
research).  
 
12. Ethical and regulatory aspects 
The investigators are responsible for ensuring that the study is conducted in 
accordance with the Declaration of Helsinki and the rules for Good Clinical Practice 
and the corresponding regulations. 
Patient information and consent 
It is the responsibility of the investigators and participating centers to explain the study 
to each patient and obtain consent signatures before any study-specific procedures 
are performed. 
Participants have the right to withdraw their consent. If not specified in more detail, all 
data traceable to this study participant will be deleted as quickly as possible. At the 
patient's request, it is also possible to anonymize the data set immediately by 
terminating the follow-up interval. Data records that have already been anonymized 
cannot be assigned retroactively and therefore cannot be deleted. 
Approval of the Ethics Committee 
The study will only be conducted with the approval of the responsible ethics committee. 
Amendments 
Amendments to the study protocol are submitted in writing to the ethics committee. 

 
 
22 
Study: ColoReg 
Study protocol, version no.: 0.4_RBK, 10.03.2024 
 
 
 

 
 
23 
Study: ColoReg 
Study protocol, version no.: 0.4_RBK, 10.03.2024 
 
13. Index 
AI:  
 
artificial intelligence 
for example:  for example 
if applicable:  
if applicable 
vs:  
 
versus 
EMR:   
Endoscopic mucosal dissection 
ESD:   
Endoscopic submucosal dissection 
EFTR:  
Endoscopic full wall resection  
incl:   
inclusive 
R0:  
 
Microscopically complete ablation 
H0:  
 
Null hypothesis  
n:  
 
number 
GDPR:  
General Data Protection Regulation 
AES:   
Advanced Encryption Standard  
above:  
 
Mentioned above 
 
14. Attachments 
- 
Patient information 
- 
Declaration of consent