Cap-fitted Colonoscopy: a Randomized, Tandem Colonoscopy Study of Adenoma Miss Rates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00577083
First received: December 11, 2007
Last updated: February 24, 2016
Last verified: February 2016
Results First Received: July 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Screening
Condition: Polyps
Intervention: Device: Cap-fitted colonoscopy

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
No Cap First, Then Cap-fitted

no cap on the end of the colonoscope for the first insertion

Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.

Initial Cap-fitted First, Then No Cap

Initial cap-fitted colonoscopy for the first insertion

Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.


Participant Flow for 3 periods

Period 1:   First Intervention (14 Days)
    No Cap First, Then Cap-fitted     Initial Cap-fitted First, Then No Cap  
STARTED     48     52  
COMPLETED     48     52  
NOT COMPLETED     0     0  

Period 2:   Washout (14 Days)
    No Cap First, Then Cap-fitted     Initial Cap-fitted First, Then No Cap  
STARTED     48     52  
COMPLETED     48     52  
NOT COMPLETED     0     0  

Period 3:   Second Intervention (14days)
    No Cap First, Then Cap-fitted     Initial Cap-fitted First, Then No Cap  
STARTED     48     52  
COMPLETED     48     52  
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.
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Reporting Groups
  Description
No Cap First, Then Cap Fitted

no cap on the end of the colonoscope for the first insertion

Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.

Initial Cap-fitted First Then No Cap

Initial cap-fitted colonoscopy for the first insertion

Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination.

Total Total of all reporting groups

Baseline Measures
    No Cap First, Then Cap Fitted     Initial Cap-fitted First Then No Cap     Total  
Number of Participants  
[units: participants]
  48     52     100  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     48     52     100  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     19     24     43  
Male     29     28     57  
Region of Enrollment  
[units: participants]
     
United States     48     52     100  



  Outcome Measures

1.  Primary:   Number of Adenomas   [ Time Frame: after the second colonoscopy is completed ]

2.  Secondary:   Time for Examination Will be Measured With a Stopwatch, and the Stopwatch Will be Stopped at Any Time a Polyp is Located and Restarted When the Polyp Has Been Removed and Retrieved.   [ Time Frame: after 2nd colonoscopy was completed in 24hrs ]
Results not yet reported.   Anticipated Reporting Date:   08/2017   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


Results Point of Contact:  
Name/Title: Douglas K Rex, MD
Organization: Indiana University
phone: 317-948-8741
e-mail: drex@iu.edu


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

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00577083     History of Changes
Other Study ID Numbers: 0501-30
Study First Received: December 11, 2007
Results First Received: July 27, 2015
Last Updated: February 24, 2016
Health Authority: United States: Institutional Review Board