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The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal.
The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy.
The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp detection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endocuff-assisted colonoscopy | Active Comparator | Endocuff-assisted colonoscopy |
|
| Standard colonoscopy | Active Comparator | Standard Colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoCuff-assisted colonoscopy | Device | EC-assisted colonoscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| adenoma detection rate | completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body. | 25 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| polyp detection rate | 1 Week | |
| number of LGIN and HGIN adenomas detected | LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia | one week |
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Inclusion Criteria:
indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Meister, M.D. | Helios Albert-Schweitzer-Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Göttingen | Göttingen | 37575 | Germany | |||
| HELIOS St. Marienberg Hospital Helmstedt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25470133 | Derived | Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014. |
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| ID | Term |
|---|---|
| D011127 | Polyps |
| D000236 | Adenoma |
| D009369 | Neoplasms |
| D003110 | Colonic Neoplasms |
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Standard colonoscopy |
| Device |
Standard colonoscopy |
|
| polyp distribution | 25 minutes |
| procedure time | 25 Minutes |
| withdrawal time | without intervention time due to polypectomy | 10 Minutes |
| ileum intubation rate | 10 minutes |
| total colonoscopy rate | 25 minutes |
| adverse events | perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy | 25 minutes |
| Helmstedt |
| 38350 |
| Germany |
| Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital | Northeim | 37154 | Germany |
| HELIOS Medical Center Siegburg, Department of Gastroenterology | Siegburg | 53721 | Germany |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D007417 | Intestinal Polyps |