Endoscopy Nurse Participation in Adenoma Detection Rate D... | NCT01124266

Studies
Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy

NCT01124266

Sponsor

Soon Chun Hyang University

Status

Completed

Last Update Posted

Feb 17, 2011Estimated

Enrollment

844Actual

Phase

Phase 4

Conditions

Polyp
Adenomatous Polyp
Colonoscopy

Interventions

standard of care colonoscopy
standard of care colonoscopy

Countries

South Korea

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

May 2010

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 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

May 14, 2010

First Submission Date that Met QC Criteria

May 14, 2010

First Posted Date

May 17, 2010Estimated

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

Feb 16, 2011

Last Update Posted Date

Feb 17, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Soon Chun Hyang UniversityOTHER

Collaborators

Name	Class
Kangbuk Samsung Hospital	OTHER
Hanyang University Guri Hospital	OTHER
Dankook University	OTHER
Incheon St.Mary's Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Colorectal cancer (CRC) is the second most common cancer and the fourth leading cause of cancer death in Korea. Colonoscopy with polypectomy decreases the incidence and mortality from colorectal cancer. However, significant lesions can be missed during colonoscopy. Recent retrospective studies have shown that fellow involvement as a second observer may increase adenoma detection rate in colonoscopy.

The aim of this prospective, multicenter, randomized study is to evaluate the impact when endoscopy nurse participate in adenoma detection during screening colonoscopy. The primary outcome measure is the adenoma detection rate (ADR).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

844Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
endoscopist only	Experimental		Procedure: standard of care colonoscopy
nurse participation	Experimental		Procedure: standard of care colonoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standard of care colonoscopy	Procedure	Single inspection by endoscopist during colonoscopy	endoscopist only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
adenoma detection rate		1 year

Secondary Outcomes

Measure	Description	Time Frame
subjects with at least one polyp		1 year
Subjects with at least one adenoma		1 year
total number of polyp

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age over 50
screening colonoscopy

Exclusion Criteria:

History of colorectal surgery
History of hereditary colorectal cancers or polyposis syndrome
Gastrointestinal bleeding
Inflammatory bowel diseases
Inability to provide informed consent
Pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chang Kyun Lee, MD, PhD	Soon Chun Hyang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dankook University Hospital		Cheonan			South Korea
Soon Chun Hyang University Cheonan Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18759826	Background	Rogart JN, Siddiqui UD, Jamidar PA, Aslanian HR. Fellow involvement may increase adenoma detection rates during colonoscopy. Am J Gastroenterol. 2008 Nov;103(11):2841-6. doi: 10.1111/j.1572-0241.2008.02085.x. Epub 2008 Aug 27.
20117245	Background	Peters SL, Hasan AG, Jacobson NB, Austin GL. Level of fellowship training increases adenoma detection rates. Clin Gastroenterol Hepatol. 2010 May;8(5):439-42. doi: 10.1016/j.cgh.2010.01.013. Epub 2010 Feb 1.

ID	Term
D011127	Polyps
D018256	Adenomatous Polyps
D000236	Adenoma
D004194	Disease

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type