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The aim of the study is to perform a prospective, multicenter research comparing capsule endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer specifically in a high risk population (sensibility, specificity, NPV, PPV and diagnostic accuracy). The investigators will used the Pillcam IIâ„¢ colon capsule (second generation) and a high resolution colonoscope (with high definition). Both procedures will be perform in the same day with an adapted bowel preparation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparison of capsule endoscopy Pillcam IIâ„¢ versus colonoscopy | Device | On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | The investigators want to know if the capsule endoscopie is more or less effective than colonoscopy to detect lesion or abdominal cancer. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores on the Visual Analog Scale | Presence of at least one polyp at capsule endoscopy and colonoscopy with both operators unaware of each other's findings until completion of the procedures. Comparison of the different class of size for all polyps Comparison of Kudo and Paris classification of the polyps at endoscopy capsule and colonoscopy Tolerance, pain and discomfort between the both procedure Acceptability of both procedure at day 1 and day 7 Accuracy of the localization of the polyp or the lesion at the capsule endosocpy comparated with the colonoscopy topography (Gold standard). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HEBUTERNE Xavier, PU-PH | Digestive department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive department - Archet hospital | Nice | 06000 | France | |||
| Gastro entérology department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28554656 | Derived | Parodi A, Vanbiervliet G, Hassan C, Hebuterne X, De Ceglie A, Filiberti RA, Spada C, Conio M. Colon capsule endoscopy to screen for colorectal neoplasia in those with family histories of colorectal cancer. Gastrointest Endosc. 2018 Mar;87(3):695-704. doi: 10.1016/j.gie.2017.05.023. Epub 2017 May 26. |
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| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 7 days |
| Sanremo |
| Italy |