Full Spectrum vs. Standard Forward-viewing Colonoscopy
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ClinicalTrials.gov Identifier: NCT02117674 |
Recruitment Status :
Completed
First Posted : April 21, 2014
Last Update Posted : December 31, 2015
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Condition or disease | Intervention/treatment | Phase |
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Colon Neoplasms | Procedure: standard forward-viewing colonoscopy Procedure: full-spectrum colonoscopy Procedure: right colon retroflexion | Not Applicable |
We changed the anticipated number of subjects enrollment for study: NCT02117674 from 120 to 200 based on the following sample size estimation:
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 246 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Full Spectrum vs. Standard Forward-viewing Colonoscopy With and Without Right-colon Retroflexion: a Randomized, Bicentric Back-to-back Study |
Study Start Date : | April 2014 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | August 2015 |
Arm | Intervention/treatment |
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Active Comparator: standard forward-viewing colonoscopy
polyp detection with standard forward-viewing colonoscopy polyp detection in the right colon with scope retroflexion
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Procedure: standard forward-viewing colonoscopy
examination of the colon with a conventional colonoscope
Other Name: conventional colonoscopy Procedure: full-spectrum colonoscopy examination of the colon with full-spectrum colonoscope
Other Name: fuse endoscopy Procedure: right colon retroflexion examination of the right colon with scope retroflexion (both with conventional and fuse scope)
Other Name: retroflexion |
Active Comparator: full-spectrum colonoscopy
polyp detection with full-spectrum colonoscopy polyp detection in the right colon with scope retroflexion
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Procedure: standard forward-viewing colonoscopy
examination of the colon with a conventional colonoscope
Other Name: conventional colonoscopy Procedure: full-spectrum colonoscopy examination of the colon with full-spectrum colonoscope
Other Name: fuse endoscopy Procedure: right colon retroflexion examination of the right colon with scope retroflexion (both with conventional and fuse scope)
Other Name: retroflexion |
- polyp detection rate [ Time Frame: one week ]per colon segment and for the entire colon
- colonoscopy completion [ Time Frame: one week ]colonoscopy completion rate
- procedure time [ Time Frame: one week ]intubation and withdrawal time
- adverse events [ Time Frame: one week ]adverse events rate
- endoscopist's satisfaction [ Time Frame: one week ]endoscopist's satisfaction quantified using a scale from 0 (not satisfied) to 10 (completely satisfied)
- feasibility of the retroflexion in the right colon by trainee [ Time Frame: one week ]feasibility of retroflexion in the right colon by trainee, meaning if the trainee managed to perform the right colon retroflexion or not
- feasibility of retroflexion in the right colon by the consultant [ Time Frame: one week ]feasibility of retroflexion in the right colon by the consultant, meaning if the consultant managed to perform the right colon retroflexion or not
- patients' satisfaction [ Time Frame: one week ]patients' satisfaction, quantified using a scale from 0 (not satisfied at all) to 10 (completely satisfied)

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adults undergoing elective screening or surveillance colonoscopy
- symptomatic adults with indication for colonoscopy
Exclusion Criteria:
- age over 80 years
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117674
Greece | |
417 Nimts Veterans Hopsital | |
Athens, Greece, 11521 | |
Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Unit, Attikon University General Hospital | |
Athens, Greece, 12462 |
Study Director: | KONSTANTINOS TRIANTAFYLLOU, Prof | Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Unit, Attikon University General Hospital, University of Athens, Greece | |
Study Director: | GEORGE ALEXANDRAKIS, Dr | 417 NIMTS VETERANS HOSPITAL |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | ATHANASIOS SIOULAS, Dr, Attikon Hospital |
ClinicalTrials.gov Identifier: | NCT02117674 |
Other Study ID Numbers: |
FUSE-001 |
First Posted: | April 21, 2014 Key Record Dates |
Last Update Posted: | December 31, 2015 |
Last Verified: | December 2015 |
colonoscopy adenoma detection rate full spectrum colonoscopy right colon retroflexion feasibility |
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |