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Colon NeoplasmsNCT02117674

Full Spectrum vs. Standard Forward-viewing Colonoscopy

A study testing standard forward-viewing colonoscopy, full-spectrum colonoscopy and right colon retroflexion in people with Colon Neoplasms, run by Attikon Hospital at 2 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colon Neoplasms
What is being tested?
standard forward-viewing colonoscopy, full-spectrum colonoscopy and right colon retroflexion
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
2 sitesGreece
Study dates
Apr 2014to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adults undergoing elective screening or surveillance colonoscopy
  • symptomatic adults with indication for colonoscopy

Who cannot join

  • age over 80 years
  • poor overall health (ASA III, IV)
  • recent abdominal surgery
  • presence of abdominal wall hernias
  • active colitis
  • multiple right colon diverticula
Show all 9Show fewer
  • previous bowel resection
  • inflammatory bowel disease
  • polyposis syndromes

Trial locations and contacts

2 sites in 1 country.

Greece2 sites

  • 417 Nimts Veterans Hopsital

    Athens, 11521

  • Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Unit, Attikon University General Hospital

    Athens, 12462

Other trials in Greece

About this study

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

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.

Read the 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.

Conditions
Colon Neoplasms
Being tested
standard forward-viewing colonoscopy, full-spectrum colonoscopy, right colon retroflexion
Keywords
colonoscopy, adenoma detection rate, full spectrum colonoscopy, right colon retroflexion, feasibility
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard forward-viewing colonoscopyProcedure or surgery

    Also called conventional colonoscopy

    examination of the colon with a conventional colonoscope

  • full-spectrum colonoscopyProcedure or surgery

    Also called fuse endoscopy

    examination of the colon with full-spectrum colonoscope

  • right colon retroflexionProcedure or surgery

    Also called retroflexion

    examination of the right colon with scope retroflexion (both with conventional and fuse scope)

Study groups in NCT02117674
Study groupRoleWhat they receive
standard forward-viewing colonoscopyActive comparatorpolyp detection with standard forward-viewing colonoscopy polyp detection in the right colon with scope retroflexion
Receives: Procedure: standard forward-viewing colonoscopy; Procedure: full-spectrum colonoscopy; Procedure: right colon retroflexion
full-spectrum colonoscopyActive comparatorpolyp detection with full-spectrum colonoscopy polyp detection in the right colon with scope retroflexion
Receives: Procedure: standard forward-viewing colonoscopy; Procedure: full-spectrum colonoscopy; Procedure: right colon retroflexion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. polyp detection rate

    per colon segment and for the entire colon

    Measured: one week

Secondary outcomes (7)

  1. colonoscopy completion

    colonoscopy completion rate

    Measured: one week

  2. procedure time

    intubation and withdrawal time

    Measured: one week

  3. adverse events

    adverse events rate

    Measured: one week

  4. endoscopist's satisfaction

    endoscopist's satisfaction quantified using a scale from 0 (not satisfied) to 10 (completely satisfied)

    Measured: one week

  5. 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

    Measured: one week

  6. 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

    Measured: one week

  7. patients' satisfaction

    patients' satisfaction, quantified using a scale from 0 (not satisfied at all) to 10 (completely satisfied)

    Measured: one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJul 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02117674
Sponsor's protocol ID
FUSE-001
Status last verified
Dec 2015
First submitted
14 Apr 2014
Last updated
31 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21679946

  • 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.

    PubMed 23939509

  • 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.

    PubMed 28107765

Questions about this trial

What is this clinical trial studying?

A study testing standard forward-viewing colonoscopy, full-spectrum colonoscopy and right colon retroflexion in people with Colon Neoplasms, run by Attikon Hospital at 2 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

polyp detection rate (time frame: one week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02117674, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2015; AzTrials last refreshed its copy on 28 Oct 2026.

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