Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy

Phase 4

Completed

• Conditions: Polyp; Adenomatous Polyp; Colonoscopy
• Interventions: Procedure: standard of care colonoscopy

• Registration Number: NCT01124266
• Lead Sponsor: Soon Chun Hyang University

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 available

Study Timeline

• Status Verified: 2010-05
• Study Start: 2010-05
• Study First Submitted: 2010-05-14
• Study First Submitted QC: 2010-05-14
• Study First Posted: 2010-05-17
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-02-16
• Last Update Posted: 2011-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 844

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endoscopist only	standard of care colonoscopy	-
nurse participation	standard of care colonoscopy	-

Primary Outcome Measures

Name	Time	Method
adenoma detection rate	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of

Soon Chun Hyang University Cheonan Hospital; 🇰🇷 Cheonan, Korea, Republic of

Hanyang university Guri Hospital; 🇰🇷 Guri, Korea, Republic of

Dankook University Hospital; 🇰🇷 Cheonan, Korea, Republic of

The Catholic University Incheon St. Mary's Hospital; 🇰🇷 Incheon, Korea, Republic of

Kyung Hee University Gangdong Hospital; 🇰🇷 Seoul, Korea, Republic of