Colorectal Polyp Resection Adequacy | NCT02217085

Studies
Colorectal Polyp Resection Adequacy

NCT02217085

Sponsor

Rush University Medical Center

Status

Completed

Last Update Posted

Aug 23, 2022Actual

Enrollment

288Actual

Phase

Not provided

Conditions

Polyp Resection Adequacy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Jun 30, 2022Actual

First Submitted Date

Jul 14, 2014

First Submission Date that Met QC Criteria

Aug 13, 2014

First Posted Date

Aug 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2022

Last Update Posted Date

Aug 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

288Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incomplete resection rates in polyps from Group 1 (clear margins) versus Group 2 (positive margins).	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.	Between 3-6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Adults aged 40 to 80 who are undergoing screening or surveillance colonoscopy for colorectal adenomatous polyps.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rush University Medical Center		Chicago	Illinois	60612	United States

Condition Browse Module

MeSH Terms

ID	Term
D011127	Polyps

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

Not provided