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Complete Histologic Resection of Adenomatous Polyps? (CARE)

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ClinicalTrials.gov Identifier: NCT01224444
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : January 12, 2015
Last Update Posted : January 12, 2015
Sponsor:
Collaborator:
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
Enrollment 269
Recruitment Details  
Pre-assignment Details 1429 patients were consented, of which 269 met inclusion criteria.
Arm/Group Title All Adenomatous Polyps
Hide Arm/Group Description Standard polypectomy snare of adenomatous polyps (included serrated adenomas) from ≥5mm to ≤20mm.
Period Title: Overall Study
Started 269
Completed 269
Not Completed 0
Arm/Group Title All Adenomatous Polyps
Hide Arm/Group Description Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.
Overall Number of Baseline Participants 269
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 269 participants
63.4  (9.1)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 269 participants
<=18 years
0
   0.0%
Between 18 and 65 years
167
  62.1%
>=65 years
102
  37.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 269 participants
Female
43
  16.0%
Male
226
  84.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 269 participants
269
1.Primary Outcome
Title Percent of Incompletely Resected Adenomatous Polyps
Hide Description Proportion of incompletely resected adenomatous polyps (5 to 20mm), defined by remaining adenomatous tissue in marginal biopsies after snare resection.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Adenomatous Polyps
Hide Arm/Group Description:
Adenomatous polyps (included serrated adenomas) ≥5mm and ≤20mm.
Overall Number of Participants Analyzed 269
Overall Number of Units Analyzed
Type of Units Analyzed: N of adenomatous polyps
346
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of incomplete resection
10.1
(6.9 to 13.3)
2.Secondary Outcome
Title Incomplete Adenoma Resection of Small and Large Adenomas
Hide Description Comparison of the proportion of incompletely resected adenomatous polyps by size (5-9mm versus 10-20mm).
Time Frame 1 year
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Adenomatous Polyps
Hide Arm/Group Description Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.
All-Cause Mortality
All Adenomatous Polyps
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Adenomatous Polyps
Affected / at Risk (%)
Total   0/269 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Adenomatous Polyps
Affected / at Risk (%)
Total   0/269 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Heiko Pohl
Organization: White River Junction VA
Phone: 802-295-9363 ext 5595
EMail: heiko.pohl@dartmouth.edu
Layout table for additonal information
Responsible Party: Dr. Heiko Pohl, White River Junction Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01224444    
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