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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

Tracking Information
First Submitted Date  ICMJE April 14, 2014
First Posted Date  ICMJE April 21, 2014
Last Update Posted Date December 31, 2015
Study Start Date  ICMJE April 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2014)
polyp detection rate [ Time Frame: one week ]
per colon segment and for the entire colon
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2014)
  • colonoscopy completion [ Time Frame: one week ]
    colonoscopy completion rate
  • procedure time [ Time Frame: one week ]
    intubation and withdrawal time
  • adverse events [ Time Frame: one week ]
    adverse events rate
  • endoscopist's satisfaction [ Time Frame: one week ]
    endoscopist's satisfaction quantified using a scale from 0 (not satisfied) to 10 (completely satisfied)
  • 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
  • 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
  • patients' satisfaction [ Time Frame: one week ]
    patients' satisfaction, quantified using a scale from 0 (not satisfied at all) to 10 (completely satisfied)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Full Spectrum vs. Standard Forward-viewing Colonoscopy
Official Title  ICMJE Full Spectrum vs. Standard Forward-viewing Colonoscopy With and Without Right-colon Retroflexion: a Randomized, Bicentric Back-to-back Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Colon Neoplasms
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: standard forward-viewing colonoscopy
    polyp detection with standard forward-viewing colonoscopy polyp detection in the right colon with scope retroflexion
    Interventions:
    • Procedure: standard forward-viewing colonoscopy
    • Procedure: full-spectrum colonoscopy
    • Procedure: right colon retroflexion
  • Active Comparator: full-spectrum colonoscopy
    polyp detection with full-spectrum colonoscopy polyp detection in the right colon with scope retroflexion
    Interventions:
    • Procedure: standard forward-viewing colonoscopy
    • Procedure: full-spectrum colonoscopy
    • Procedure: right colon retroflexion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2015)
246
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2014)
120
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02117674
Other Study ID Numbers  ICMJE FUSE-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ATHANASIOS SIOULAS, Attikon Hospital
Study Sponsor  ICMJE Attikon Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Attikon Hospital
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP