Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
246 participants
INTERVENTIONAL
2014-04-30
2015-08-31
Brief Summary
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Detailed Description
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Tandem colonoscopies studies results, show that novel endoscopic technologies detect about 20% more adenomas than those conventional colonoscopy does (missed adenomas). Since FUSE colonoscopy cannot be considered as a perfect examination, we hypothesize that conventional colonoscopy will detect one third of the missed adenomas that FUSE detects in a similar setting. Therefore a sample size of 120 adenomas achieves 80% power to detect an odds ratio of 3.0 using a two-sided McNemar test with a significance level of 0.05. The odds ratio is equivalent to a difference between two paired proportions of 14% which occurs when the proportion of detected missed adenomas during FUSE is 21% and the proportion of missed adenomas during conventional colonoscopy is 7%. During one year period before the study initiation, our colonoscopy performance quality data show that we detect a mean number of adenomas per patient equal of 0.7 in a population similar to the one recruited in our study. Therefore, 172 patients overall will be required to detect 120 adenomas. Given the uncertainty of our estimation and in order to cope with patients exclusions, withdrawals and unexpected incomplete colonoscopies, we decided to recruit 200 patients.
A more extensive description regarding the investigators study is provided in the following fields.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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standard forward-viewing colonoscopy
polyp detection with standard forward-viewing colonoscopy polyp detection in the right colon with scope retroflexion
standard forward-viewing colonoscopy
examination of the colon with a conventional colonoscope
full-spectrum colonoscopy
examination of the colon with full-spectrum colonoscope
right colon retroflexion
examination of the right colon with scope retroflexion (both with conventional and fuse scope)
full-spectrum colonoscopy
polyp detection with full-spectrum colonoscopy polyp detection in the right colon with scope retroflexion
standard forward-viewing colonoscopy
examination of the colon with a conventional colonoscope
full-spectrum colonoscopy
examination of the colon with full-spectrum colonoscope
right colon retroflexion
examination of the right colon with scope retroflexion (both with conventional and fuse scope)
Interventions
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standard forward-viewing colonoscopy
examination of the colon with a conventional colonoscope
full-spectrum colonoscopy
examination of the colon with full-spectrum colonoscope
right colon retroflexion
examination of the right colon with scope retroflexion (both with conventional and fuse scope)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* symptomatic adults with indication for colonoscopy
Exclusion Criteria
* poor overall health (ASA III, IV)
* recent abdominal surgery
* presence of abdominal wall hernias
* active colitis
* multiple right colon diverticula
* previous bowel resection
* inflammatory bowel disease
* polyposis syndromes
18 Years
80 Years
ALL
No
Sponsors
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Attikon Hospital
OTHER
Responsible Party
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ATHANASIOS SIOULAS
Dr
Principal Investigators
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KONSTANTINOS TRIANTAFYLLOU, Prof
Role: STUDY_DIRECTOR
Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Unit, Attikon University General Hospital, University of Athens, Greece
GEORGE ALEXANDRAKIS, Dr
Role: STUDY_DIRECTOR
417 NIMTS VETERANS HOSPITAL
Locations
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417 Nimts Veterans Hopsital
Athens, , Greece
Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Unit, Attikon University General Hospital
Athens, , Greece
Countries
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References
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Hewett DG, Rex DK. Miss rate of right-sided colon examination during colonoscopy defined by retroflexion: an observational study. Gastrointest Endosc. 2011 Aug;74(2):246-52. doi: 10.1016/j.gie.2011.04.005. Epub 2011 Jun 15.
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.
Papanikolaou IS, Apostolopoulos P, Tziatzios G, Vlachou E, Sioulas AD, Polymeros D, Karameris A, Panayiotides I, Alexandrakis G, Dimitriadis GD, Triantafyllou K. Lower adenoma miss rate with FUSE vs. conventional colonoscopy with proximal retroflexion: a randomized back-to-back trial. Endoscopy. 2017 May;49(5):468-475. doi: 10.1055/s-0042-124415. Epub 2017 Jan 20.
Other Identifiers
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FUSE-001
Identifier Type: -
Identifier Source: org_study_id