A Prospective Randomized Comparison of the Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®)

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effect of ENDOCUFF VISION® (caps with soft, about 1 cm long lateral feet of rubber (Endocuff) to flatten the colon folds) on ADR in a real-life setting (general practices) and in a homogenous patient collective (screening colonoscopies only). It is a prospective randomized multi centric study, with participation of at least 10 study sites (private practice). The study is an inverstigator-initiated trial (IIT). Depending on the randomization (closed envelope), the patients are examined with the standard instruments without or with ENDOCUFF VISION®. Group 1: screening colonoscopy with standard colonoscopes with ENDOCUFF VISION® Group 2: screening colonoscopy with standard colonoscopes without cap

Detailed Description
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Colonoscopy is currently the best method for the detection of colon carcinomas and, as precursor, adenomas, since these can also be biopsied and removed. Therefore, the screening colonoscopy was introduced at the end of 2002 (covered by state insurance) from the age of 55. The main quality parameter for outcome quality is the adenoma detection rate (ADR), which correlates with the rate of the carcinomas prevented. However, since even smaller polyps, especially if they are flat or sunken, may be relevant for colon cancer development, the aim of colonoscopy should be to be able to recognize and remove as many adenomas as possible. There is a need to optimize the efficiency of screening colonoscopy by increasing the rate of adenoma detection, as it is known from many studies that approximately 15-30% of adenomas can be missed- even though the adenoma rate in the German screening colonoscopy register continues to increase over the years and currently stands at 28%. Previous studies on the increase of the adenoma detection rate by endoscopy concerning newer endoscope technologies including conventional caps have been almost entirely negative. For about 2 years, a newer version of ENDOCUFF VISION® caps (caps with soft, about 1 cm long lateral feet of rubber (Endocuff) to flatten the colon folds) is available which has already been used in about 8,000 colonoscopies in Germany and another 10,000 colonoscopies in Europe; there are no studies on this version of Endocuff caps. The aim of this study is to evaluate the effect of ENDOCUFF VISION® in a real-life setting (general practices) and in a homogenous patient collective (screening colonoscopies only). It is a prospective randomized multi centric study, with participation of at least 10 study sites (private practice). The study is an inverstigator-initiated trial (IIT). A new technique for ADR improvement within colonoscopy can only be tested in a comparative study in two groups comparing the adenoma rate between the two groups. An independent gold standard does not exist in this sense, but the confirmation by the endoscopically taken histology serves as gold standard for the diagnosis adenoma. The alternative of double examinations (tandem colonoscopy) in each patient is in the setting of private practice not feasible. Depending on the randomization (closed envelope), the patients are examined with the standard instruments without or with ENDOCUFF VISION®. Group 1: screening colonoscopy with standard colonoscopes with ENDOCUFF VISION® Group 2: screening colonoscopy with standard colonoscopes without cap

Official Title
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A Prospective Randomized Comparison of the Adenoma Detection Rate in Screening Colonoscopy With and Without a Disposable Cap (ENDOCUFF VISION®)

Conditions
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Adenoma Detection Rate

Intervention / Treatment
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* Procedure: Endocuff group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 55 years who voluntarily undergo a screening colonoscopy information and signed declaration of consent Exclusion Criteria: symptoms that may indicate a colonic disease rectal/colonic bleeding known colon disease for further diagnosis, e.g. Carcinoma, polyps for erosion, inflammatory bowel disease, stenosis follow-up/surveillance after colon carcinoma surgery or polypectomy anticoagulant drugs that make a biopsy or polypectomy impossible poor general condition (from ASA (American Society of Anesthesiologists Classification) III) partial/incomplete colonoscopy planned

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I Endocuff group<br>Group I Endocuff cap use | Procedure: Endocuff group<br>* Endocuff Vision cap on Standard colonoscope<br>|
| Group II standard colonoscope<br>Group II standard colonoscope, no further device used | Procedure: Endocuff group<br>* Endocuff Vision cap on Standard colonoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rate (ADR) in the two study groups | Differences in ADR with or without the new disposable ENDOCUFF VISION® cap. Hypothesis: Endocuff Vision improves the adenoma detection rate (ADR) by about 25% compared to the comparison group. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADR (all adenoma/all patients) | ADR (all adenoma/all patients) | 12 months | 
| assessment of adenoma subgroups by location | differences in adenoma subgroups (between intestinal folds with good accessibility, between intestinal folds with poor accessibility, on top of intestinal fold, behind intestinal fold ) | 12 months | 
| assessment of adenoma subgroups by size | measured by comparison with size of snare or forceps | 12 months | 
| assessment of adenoma subgroups by form | stem-based, broad-based, flat adenoma | 12 months | 
| assessment of adenoma subgroups by histology | loiw grade intraepithelial neoplasia (LGIN), high grade intraepithelial neoplasia (HGIN), sessile serrated Adenoma (SSA), Carcinoma | 12 months | 
| assessment of adenoma subgroups by adjustability | adjustability of adenoma by colonoscope on a score scale from 1(very good) - 6 (poor) | 12 months | 
| assessment of adenoma subgroups by resection practice | resection of adenoma by biopsy, polypectomy, resection by forceps, none | 12 months | 
| Intervention times | duration of Intervention | through study completion, an average of 1 year | 
| procedure technique | technical aspects of polypectomy/biopsy | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADR, adenoma, polyp, colon, screening, colorectal carcinoma (CRC), cap, endoscopy, colonoscopy, private practice