Clinical trial NCT02117674: Full Spectrum vs. Standard Forward-viewing Colonoscopy
Official title: Full Spectrum vs. Standard Forward-viewing Colonoscopy With and Without Right-colon Retroflexion: a Randomized, Bicentric Back-to-back Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Neoplasms
Keywords: colonoscopy
adenoma detection rate
full spectrum colonoscopy
right colon retroflexion
feasibility
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: polyp detection rate
timeFrame: one week
Secondary outcomes:
measure: colonoscopy completion
timeFrame: one week
measure: procedure time
timeFrame: one week
measure: adverse events
timeFrame: one week
measure: endoscopist's satisfaction
timeFrame: one week
measure: feasibility of the retroflexion in the right colon by trainee
timeFrame: one week
measure: feasibility of retroflexion in the right colon by the consultant
timeFrame: one week
measure: patients' satisfaction
timeFrame: one week
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 417 Nimts Veterans Hopsital
city: Athens
country: Greece
facility: Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Unit, Attikon University General Hospital
Study officials:
affiliation: Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Unit, Attikon University General Hospital, University of Athens, Greece
name: KONSTANTINOS TRIANTAFYLLOU, Prof
role: STUDY_DIRECTOR
affiliation: 417 NIMTS VETERANS HOSPITAL
name: GEORGE ALEXANDRAKIS, Dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.