The Use of Narrow Band Imaging in Screening Colonoscopy

This study has been completed.
Sponsor:
Information provided by:
Valduce Hospital
ClinicalTrials.gov Identifier:
NCT00908648
First received: January 22, 2009
Last updated: April 2, 2009
Last verified: April 2009
Results First Received: January 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind;   Primary Purpose: Diagnostic
Condition: Colonoscopy
Intervention: Procedure: Narrow Band Imaging

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Gastroenterology Unit November 2007 - April 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients undergoing incomplete procedure for inadequate bowel cleansing or failure to reach the cecum were excluded from randomization

Reporting Groups
  Description
Standard White Light use of standard white light during the withdrawal phase of colonoscopy
Narrow Band Imaging use of narrow band imaging during the withdrawal phase of colonoscopy

Participant Flow:   Overall Study
    Standard White Light     Narrow Band Imaging  
STARTED     108     103  
COMPLETED     108     103  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard White Light use of standard white light during the withdrawal phase of colonoscopy
Narrow Band Imaging use of narrow band imaging during the withdrawal phase of colonoscopy
Total Total of all reporting groups

Baseline Measures
    Standard White Light     Narrow Band Imaging     Total  
Number of Participants  
[units: participants]
  108     103     211  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     90     88     178  
>=65 years     18     15     33  
Age  
[units: years]
Mean ± Standard Deviation
  61.1  ± 5.8     59.6  ± 5.3     60.8  ± 5.4  
Gender  
[units: participants]
     
Female     47     47     94  
Male     61     56     117  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adenoma Detection   [ Time Frame: duration of colonoscopy procedure ]

2.  Secondary:   Detection of Flat and/or Depressed Adenomas   [ Time Frame: duration of colonoscopy procedure ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr Vittorio Terruzzi, Director of Gastroenterology Unit
Organization: Gastroenterology Unit, Valduce Hospital - Como - Italy
phone: +39031324009
e-mail: vterruzzi@valduce.it


Publications:

Responsible Party: Vittorio Terruzzi, MD., Valduce Hospital, Department of Gastroenterology
ClinicalTrials.gov Identifier: NCT00908648     History of Changes
Other Study ID Numbers: NBI-01
Study First Received: January 22, 2009
Results First Received: January 22, 2009
Last Updated: April 2, 2009
Health Authority: Italy: Ethics Committee