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The coloscopy is considered as the gold standard for screening and resection of colorectal adenomas. However the literature reports that the rate of omitted adenoma is still high (24 to 41%). The development of the FUSE system (Endochoice, USA) allows a larger field of view with a projection onto 3 screens (330° vision). A pilot study and a randomized multicentre has demonstrated the feasibility with a significant improvement of the rate of detected adenomas. This first study in France concerning this technology has the objectives to demonstrate the feasibility in France, the safety and to compare the rate of detected adenomas with data of the literature.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FUSE-TM colonoscope | Device | Colonoscopy in conditions of normal security including patient clinical examination before leaving the hospital. Data collection by each operator. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Cecal intubation rate | 1 day |
| Efficacy | Absence of necessity to change of endoscope in case of progression, visualization, biopsy or resection | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Serious adverse events (perforation, uncontrolled bleeding) | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with colorectal adenoma candidate to colonoscopy of diagnostic
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe RATONE, MD | Institut Paoli-Calmettes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli Cakmettes | Marseille | Bouches du Rhône | 13009 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23939509 | Background | Gralnek IM, Segol O, Suissa A, Siersema PD, Carr-Locke DL, Halpern Z, Santo E, Domanov S. A prospective cohort study evaluating a novel colonoscopy platform featuring full-spectrum endoscopy. Endoscopy. 2013 Sep;45(9):697-702. doi: 10.1055/s-0033-1344395. Epub 2013 Aug 12. | |
| 24560453 | Background | Gralnek IM, Siersema PD, Halpern Z, Segol O, Melhem A, Suissa A, Santo E, Sloyer A, Fenster J, Moons LM, Dik VK, D'Agostino RB Jr, Rex DK. Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial. Lancet Oncol. 2014 Mar;15(3):353-60. doi: 10.1016/S1470-2045(14)70020-8. Epub 2014 Feb 20. |
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| 8978338 | Background | Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2. |
| 8978337 | Background | Rex DK, Rahmani EY, Haseman JH, Lemmel GT, Kaster S, Buckley JS. Relative sensitivity of colonoscopy and barium enema for detection of colorectal cancer in clinical practice. Gastroenterology. 1997 Jan;112(1):17-23. doi: 10.1016/s0016-5085(97)70213-0. |
| 22807609 | Background | Siersema PD, Rastogi A, Leufkens AM, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, DeMarco DC. Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup. World J Gastroenterol. 2012 Jul 14;18(26):3400-8. doi: 10.3748/wjg.v18.i26.3400. |