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

History of Changes

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 ]

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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

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Other Adverse Events

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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):

Pohl H, Srivastava A, Bensen SP, Anderson P, Rothstein RI, Gordon SR, Levy LC, Toor A, Mackenzie TA, Rosch T, Robertson DJ. Incomplete polyp resection during colonoscopy-results of the complete adenoma resection (CARE) study. Gastroenterology. 2013 Jan;144(1):74-80.e1. doi: 10.1053/j.gastro.2012.09.043. Epub 2012 Sep 25.

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

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