Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy

February 16, 2011 updated by: Soon Chun Hyang University

Can Involvement of Endoscopy Nurse Participation Increase Adenoma Detection Rate During Screening Colonoscopy?:A Prospective Multicenter Randomized Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

844

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Cheonan, Korea, Republic of
        • Dankook University Hospital
      • Cheonan, Korea, Republic of
        • Soon Chun Hyang University Cheonan Hospital
      • Guri, Korea, Republic of
        • Hanyang University Guri Hospital
      • Incheon, Korea, Republic of
        • The Catholic University Incheon St. Mary's Hospital
      • Seoul, Korea, Republic of
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of
        • Kyung Hee University Gangdong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: endoscopist only
Procedure: standard of care colonoscopy
Single inspection by endoscopist during colonoscopy
Procedure: standard of care colonoscopy
Dual inspection by both endoscopist and nurse during colonoscopy
Experimental: nurse participation
Procedure: standard of care colonoscopy
Single inspection by endoscopist during colonoscopy
Procedure: standard of care colonoscopy
Dual inspection by both endoscopist and nurse during colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adenoma detection rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
subjects with at least one polyp
Time Frame: 1 year
1 year
Subjects with at least one adenoma
Time Frame: 1 year
1 year
total number of polyp
Time Frame: 1 year
1 year
total number of adenoma
Time Frame: 1 year
1 year
Subjects with at least one advanced adenoma or cancer
Time Frame: 1 year
1 year
total number of advanced adenoma or cancer
Time Frame: 1 year
1 year
polyp and adenoma detection rate according to the endoscopists or nurse experience
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soon Chun Hyang University

Collaborators

Hanyang University
Kangbuk Samsung Hospital
Kyung Hee University Hospital at Gangdong
Incheon St.Mary's Hospital
Dankook University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 14, 2010

First Submitted That Met QC Criteria

May 14, 2010

First Posted (Estimate)

May 17, 2010

Study Record Updates

Last Update Posted (Estimate)

February 17, 2011

Last Update Submitted That Met QC Criteria

February 16, 2011

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-15 (Other Identifier: AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colonoscopy

Clinical Trials on standard of care colonoscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe