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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00765180
First Posted: October 2, 2008
Last Update Posted: November 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic

Further study details as provided by Akira Horiuchi, Showa Inan General Hospital:

Primary Outcome Measures:
  • Colorectal adenoma detection rate [ Time Frame: after colonoscopy ]

Secondary Outcome Measures:
  • Procedure time, complication [ Time Frame: after colonoscopy ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00765180


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

Responsible Party: Akira Horiuchi, Digestive Disease Center, Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT00765180     History of Changes
Other Study ID Numbers: TRE2
First Submitted: October 1, 2008
First Posted: October 2, 2008
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by Akira Horiuchi, 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