Trial Outcomes & Findings for Complete Histologic Resection of Adenomatous Polyps? (NCT NCT01224444)

Results Overview

Proportion of incompletely resected adenomatous polyps (5 to 20mm), defined by remaining adenomatous tissue in marginal biopsies after snare resection.

Recruitment status

COMPLETED

Target enrollment

269 participants

Primary outcome timeframe

1 year

Results posted on

2015-01-12

Participant Flow

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

Participant milestones

Participant milestones
Measure	All Adenomatous Polyps Standard polypectomy snare of adenomatous polyps (included serrated adenomas) from ≥5mm to ≤20mm.
Overall Study STARTED	269
Overall Study COMPLETED	269
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Complete Histologic Resection of Adenomatous Polyps?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Adenomatous Polyps n=269 Participants Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.
Age, Continuous	63.4 years STANDARD_DEVIATION 9.1 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	167 Participants n=5 Participants
Age, Categorical >=65 years	102 Participants n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	226 Participants n=5 Participants
Region of Enrollment United States	269 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Proportion of incompletely resected adenomatous polyps (5 to 20mm), defined by remaining adenomatous tissue in marginal biopsies after snare resection.

Outcome measures

Outcome measures
Measure	All Adenomatous Polyps n=346 N of adenomatous polyps Adenomatous polyps (included serrated adenomas) ≥5mm and ≤20mm.
Percent of Incompletely Resected Adenomatous Polyps	10.1 percentage of incomplete resection Interval 6.9 to 13.3

SECONDARY outcome

Timeframe: 1 year

Comparison of the proportion of incompletely resected adenomatous polyps by size (5-9mm versus 10-20mm).

Outcome measures

Outcome data not reported

Adverse Events

All Adenomatous Polyps

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heiko Pohl

White River Junction VA

Phone: 802-295-9363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place