Full Spectrum vs. Standard Forward-viewing Colonoscopy
1 other identifier
interventional
246
1 country
2
Brief Summary
The aim of this study is to evaluate FUSE-colonoscopy in terms of feasibility and its possible additive contribution in the detection of important lesions, namely polyps and cancers, compared to the standard "forward-viewing" approach, with and without the addition of the right-colon retroflexion technique, in a series of patients undergoing back-to-back screening or surveillance colonoscopies in a randomized fashion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 14, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedDecember 31, 2015
December 1, 2015
1.2 years
April 14, 2014
December 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
polyp detection rate
per colon segment and for the entire colon
one week
Secondary Outcomes (7)
colonoscopy completion
one week
procedure time
one week
adverse events
one week
endoscopist's satisfaction
one week
feasibility of the retroflexion in the right colon by trainee
one week
- +2 more secondary outcomes
Study Arms (2)
standard forward-viewing colonoscopy
ACTIVE COMPARATORpolyp detection with standard forward-viewing colonoscopy polyp detection in the right colon with scope retroflexion
full-spectrum colonoscopy
ACTIVE COMPARATORpolyp detection with full-spectrum colonoscopy polyp detection in the right colon with scope retroflexion
Interventions
examination of the colon with a conventional colonoscope
examination of the colon with full-spectrum colonoscope
examination of the right colon with scope retroflexion (both with conventional and fuse scope)
Eligibility Criteria
You may qualify if:
- adults undergoing elective screening or surveillance colonoscopy
- symptomatic adults with indication for colonoscopy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Attikon Hospitallead
Study Sites (2)
417 Nimts Veterans Hopsital
Athens, 11521, Greece
Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Unit, Attikon University General Hospital
Athens, 12462, Greece
Related Publications (3)
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.
PMID: 21679946BACKGROUNDGralnek 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.
PMID: 23939509BACKGROUNDPapanikolaou 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.
PMID: 28107765DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
April 14, 2014
First Posted
April 21, 2014
Study Start
April 1, 2014
Primary Completion
July 1, 2015
Study Completion
August 1, 2015
Last Updated
December 31, 2015
Record last verified: 2015-12