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One investigator is out-of-service due to carrying out another task.
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| Name | Class |
|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Tianjin People's Hospital | OTHER |
| Tianjin Nankai Hospital |
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The primary aim of this study is
- to explore the usefulness of Endocuff Vision in colonoscopy on adenoma detection rate (ADR).
Other aims include to explore the data below when Endocuff Vision is used.
Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT
Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve "adenoma detection rates".
A new device, called the Endocuff Vision has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy will be invited in 5 centres, recruiting a total of 1200 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endocuff Vision-assisted Colonoscopy | Active Comparator | Participants in this arm undergo Endocuff Vision-assisted colonoscopy |
|
| Standard Colonoscopy | No Intervention | Participants in this arm undergo standard colonoscopy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocuff Vision | Device | Endocuff Vision is attached to the tip of colonoscope before intubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate, ADR | ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma. | At the end of the procedure, up to 1 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp detection rate, PDR | PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp. | At the end of the procedure, up to 1 hour. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| En-Da YU | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sixth affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | 510655 | China | ||
| Shanghai Zhongshan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29363535 | Background | Ngu WS, Bevan R, Tsiamoulos ZP, Bassett P, Hoare Z, Rutter MD, Clifford G, Totton N, Lee TJ, Ramadas A, Silcock JG, Painter J, Neilson LJ, Saunders BP, Rees CJ. Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial. Gut. 2019 Feb;68(2):280-288. doi: 10.1136/gutjnl-2017-314889. Epub 2018 Jan 23. |
| Label | URL |
|---|---|
| PubMed link | View source |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003111 | Colonic Polyps |
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| OTHER |
Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).
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| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |
| Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| Tianjin Nankai Hospital | Tianjin | Tianjin Municipality | 300100 | China |
| Tianjin People's Hospital | Tianjin | Tianjin Municipality | 300121 | China |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |