Full Spectrum vs. Standard Forward-viewing Colonoscopy

December 30, 2015 updated by: ATHANASIOS SIOULAS, Attikon Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11521
        • 417 Nimts Veterans Hopsital
      • Athens, Greece, 12462
        • Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Unit, Attikon University General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard forward-viewing colonoscopy
polyp detection with standard forward-viewing colonoscopy polyp detection in the right colon with scope retroflexion
Procedure: standard forward-viewing colonoscopy
examination of the colon with a conventional colonoscope
Other Names:
  • conventional colonoscopy
Procedure: full-spectrum colonoscopy
examination of the colon with full-spectrum colonoscope
Other Names:
  • fuse endoscopy
Procedure: right colon retroflexion
examination of the right colon with scope retroflexion (both with conventional and fuse scope)
Other Names:
  • retroflexion
Active Comparator: full-spectrum colonoscopy
polyp detection with full-spectrum colonoscopy polyp detection in the right colon with scope retroflexion
Procedure: standard forward-viewing colonoscopy
examination of the colon with a conventional colonoscope
Other Names:
  • conventional colonoscopy
Procedure: full-spectrum colonoscopy
examination of the colon with full-spectrum colonoscope
Other Names:
  • fuse endoscopy
Procedure: right colon retroflexion
examination of the right colon with scope retroflexion (both with conventional and fuse scope)
Other Names:
  • retroflexion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
polyp detection rate
Time Frame: one week
per colon segment and for the entire colon
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
colonoscopy completion
Time Frame: one week
colonoscopy completion rate
one week
procedure time
Time Frame: one week
intubation and withdrawal time
one week
adverse events
Time Frame: one week
adverse events rate
one week
endoscopist's satisfaction
Time Frame: one week
endoscopist's satisfaction quantified using a scale from 0 (not satisfied) to 10 (completely satisfied)
one week
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
one week
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
one week
patients' satisfaction
Time Frame: one week
patients' satisfaction, quantified using a scale from 0 (not satisfied at all) to 10 (completely satisfied)
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Attikon Hospital

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 14, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

December 31, 2015

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUSE-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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