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Complete Histologic Resection of Adenomatous Polyps? (CARE)

This study has been completed.
Sponsor:
Collaborator:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Dr. Heiko Pohl, White River Junction VAMC
ClinicalTrials.gov Identifier:
NCT01224444
First received: October 19, 2010
Last updated: December 30, 2014
Last verified: December 2014
Results First Received: December 16, 2013  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Adenomatous Polyps
Intervention: Other: standard polypectomy snare

  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
1429 patients were consented, of which 269 met inclusion criteria.

Reporting Groups
  Description
All Adenomatous Polyps Standard polypectomy snare of adenomatous polyps (included serrated adenomas) from ≥5mm to ≤20mm.

Participant Flow:   Overall Study
    All Adenomatous Polyps
STARTED   269 
COMPLETED   269 
NOT COMPLETED   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
All Adenomatous Polyps Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.

Baseline Measures
   All Adenomatous Polyps 
Overall Participants Analyzed 
[Units: Participants]
 269 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.4  (9.1) 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   167 
>=65 years   102 
Gender 
[Units: Participants]
 
Female   43 
Male   226 
Region of Enrollment 
[Units: Participants]
 
United States   269 


  Outcome Measures

1.  Primary:   Percent of Incompletely Resected Adenomatous Polyps   [ Time Frame: 1 year ]

2.  Secondary:   Incomplete Adenoma Resection of Small and Large Adenomas   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Heiko Pohl
Organization: White River Junction VA
phone: 802-295-9363 ext 5595
e-mail: heiko.pohl@dartmouth.edu


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

Responsible Party: Dr. Heiko Pohl, White River Junction VAMC
ClinicalTrials.gov Identifier: NCT01224444     History of Changes
Other Study ID Numbers: DMS-21237
Study First Received: October 19, 2010
Results First Received: December 16, 2013
Last Updated: December 30, 2014
Health Authority: United States: Federal Government