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Comparison of Transparent Retractable Extension Device and Narrow Band Imaging on Colorectal Adenoma Detection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital
ClinicalTrials.gov Identifier:
NCT00765180
First received: October 1, 2008
Last updated: August 21, 2011
Last verified: October 2009
History of Changes
  Purpose

The investigators previously reported that colonoscopy with a transparent retractable extension (TRE) device improved the adenoma detection rate without affecting intubation and withdrawal times. On the other hand, colonoscopy using narrow band imaging (NBI) is expected to lead to higher rate s of adenoma detection. The investigators compared the effects of TRE device on colorectal adenoma detection with those of NBI.


Condition Intervention
Colorectal Cancer Screening
 Device: TRE vs. NBI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Showa Inan General Hospital:

Primary Outcome Measures:
  • Colorectal adenoma detection rate [ Time Frame: after colonoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Procedure time, complication [ Time Frame: after colonoscopy ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
The investigators evaluate beneficial effect of colonoscopy using narrow band imaging (NBI) for colorectal adenoma detection.
 Device: TRE vs. NBI
TRE NBI
Experimental: 1
The investigators evaluate the beneficial effect of colonoscopy with a transparent retractable extension (TRE) device on colorectal adenoma detection rate.
 Device: TRE vs. NBI
TRE NBI

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Exclusion Criteria:

  • Age less than 20 years old
  • Pregnant
  • American Society of Anesthesiologists class III and IV
  • Overweight (body weight > 100 kg)
  • Allergic to the drugs used or its components (soybeans or eggs)
  • Poor bowel preparation
  • Previous colorectal surgical resection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765180

Locations
Japan
Showa Inan General hospital
Komagane, Nagano, Japan, 399-4191
Sponsors and Collaborators
Showa Inan General Hospital
  More Information

No publications provided

Responsible Party: Akira Horiuchi, Digestive Disease Center, Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT00765180     History of Changes
Other Study ID Numbers: TRE2
Study First Received: October 1, 2008
Last Updated: August 21, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Showa Inan General Hospital:
colonoscopy
hood
NBI

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 21, 2013