Complete Histologic Resection of Adenomatous Polyps? (CARE)

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. Identifier: NCT01224444
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : January 12, 2015
Last Update Posted : January 12, 2015
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Dr. Heiko Pohl, White River Junction Veterans Affairs Medical Center

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Adenomatous Polyps
Intervention: Other: standard polypectomy snare

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
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 

  Baseline Characteristics

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
All Adenomatous Polyps Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.

Baseline Measures
   All Adenomatous Polyps 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 63.4  (9.1) 
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   167 
>=65 years   102 
[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.  

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information

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

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

Responsible Party: Dr. Heiko Pohl, White River Junction Veterans Affairs Medical Center Identifier: NCT01224444     History of Changes
Other Study ID Numbers: DMS-21237
First Submitted: October 19, 2010
First Posted: October 20, 2010
Results First Submitted: December 16, 2013
Results First Posted: January 12, 2015
Last Update Posted: January 12, 2015