Colorectal Polyp Resection Adequacy

Determining True Colorectal Polyp Resection Adequacy: Correlation of Endoscopic Margins With Histopathologic Margins

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02217085

Enrollment

288

Registered

2014-08-15

Start date

2014-05-31

Completion date

2022-06-30

Last updated

2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyp Resection Adequacy

Keywords

Colorectal Cancer Screening, Colon Cancer Screening, Polyps, Colonoscopy

Brief summary

The purpose of this study is to determine the best way to ensure that polyps are completely removed by evaluating the borders of the removed polyp. If a polyp is found that meets the size requirements for the study, the investigators will take extra biopsies of the margin to determine if there is any abnormal tissue or cancer at these borders.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Age 40-80

Exclusion criteria

* Coagulopathy (international normalized ratio \>2) * Inflammatory bowel disease or other active colitides * Polyps of index colonoscopy that were felt not to be completely resected or pedunculated * Familial adenomatous polyposis or hereditary polyposis * Potential hereditary cancer syndrome (Lynch Syndrome)

Design outcomes

Primary

Measure	Time frame	Description
The incomplete resection rates in polyps from Group 1 (clear margins) versus Group 2 (positive margins).	Between 3-6 months	Define the frequency of free margins versus margins that have dysplasia to the cautery site in snare polypectomy. A free margin is defined as uninvolved or normal mucosa extending to the cautery margin at the polypectomy stalk.

Countries

United States

Outcome results