Full Spectrum vs. Standard Forward-viewing Colonoscopy

Colon Neoplasms Clinical Trial

Official title:

Full Spectrum vs. Standard Forward-viewing Colonoscopy With and Without Right-colon Retroflexion: a Randomized, Bicentric Back-to-back Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02117674
• Other study ID #: FUSE-001
• Status: Completed
• Phase: N/A
• First received: April 14, 2014
• Last updated: December 30, 2015
• Start date: April 2014
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Neoplasms
• Colonic Neoplasms

Intervention

Procedure:
• 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)

Locations

Country	Name	City	State
Greece	417 Nimts Veterans Hopsital	Athens
Greece	Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Unit, Attikon University General Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	polyp detection rate	per colon segment and for the entire colon	one week
Secondary	colonoscopy completion	colonoscopy completion rate	one week
Secondary	procedure time	intubation and withdrawal time	one week
Secondary	adverse events	adverse events rate	one week
Secondary	endoscopist's satisfaction	endoscopist's satisfaction quantified using a scale from 0 (not satisfied) to 10 (completely satisfied)	one week
Secondary	feasibility of the retroflexion in the right colon by trainee	feasibility of retroflexion in the right colon by trainee, meaning if the trainee managed to perform the right colon retroflexion or not	one week
Secondary	feasibility of retroflexion in the right colon by the consultant	feasibility of retroflexion in the right colon by the consultant, meaning if the consultant managed to perform the right colon retroflexion or not	one week
Secondary	patients' satisfaction	patients' satisfaction, quantified using a scale from 0 (not satisfied at all) to 10 (completely satisfied)	one week

External Links

•   company's official site