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Full Spectrum vs. Standard Forward-viewing Colonoscopy

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ClinicalTrials.gov Identifier: NCT02117674
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
ATHANASIOS SIOULAS, Attikon Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colon Neoplasms Procedure: standard forward-viewing colonoscopy Procedure: full-spectrum colonoscopy Procedure: right colon retroflexion Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Full Spectrum vs. Standard Forward-viewing Colonoscopy With and Without Right-colon Retroflexion: a Randomized, Bicentric Back-to-back Study
Study Start Date : April 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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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 Name: conventional colonoscopy

Procedure: full-spectrum colonoscopy
examination of the colon with full-spectrum colonoscope
Other Name: fuse endoscopy

Procedure: right colon retroflexion
examination of the right colon with scope retroflexion (both with conventional and fuse scope)
Other Name: 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 Name: conventional colonoscopy

Procedure: full-spectrum colonoscopy
examination of the colon with full-spectrum colonoscope
Other Name: fuse endoscopy

Procedure: right colon retroflexion
examination of the right colon with scope retroflexion (both with conventional and fuse scope)
Other Name: retroflexion


Outcome Measures
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Primary Outcome Measures :
  1. polyp detection rate [ Time Frame: one week ]
    per colon segment and for the entire colon


Secondary Outcome Measures :
  1. colonoscopy completion [ Time Frame: one week ]
    colonoscopy completion rate

  2. procedure time [ Time Frame: one week ]
    intubation and withdrawal time

  3. adverse events [ Time Frame: one week ]
    adverse events rate

  4. endoscopist's satisfaction [ Time Frame: one week ]
    endoscopist's satisfaction quantified using a scale from 0 (not satisfied) to 10 (completely satisfied)

  5. 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

  6. 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

  7. patients' satisfaction [ Time Frame: one week ]
    patients' satisfaction, quantified using a scale from 0 (not satisfied at all) to 10 (completely satisfied)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117674


Locations
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Greece
417 Nimts Veterans Hopsital
Athens, Greece, 11521
Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Unit, Attikon University General Hospital
Athens, Greece, 12462
Sponsors and Collaborators
Attikon Hospital
Investigators
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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
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ATHANASIOS SIOULAS, Dr, Attikon Hospital
ClinicalTrials.gov Identifier: NCT02117674    
Other Study ID Numbers: FUSE-001
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015
Keywords provided by ATHANASIOS SIOULAS, Attikon Hospital:
colonoscopy
adenoma detection rate
full spectrum colonoscopy
right colon retroflexion
feasibility
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases