Colorectal Polyp Resection Adequacy

Completed

• Conditions: Polyp Resection Adequacy

• Registration Number: NCT02217085
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-08-13
• Study First Posted: 2014-08-15
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States