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OpenTrials
Completed

NCT Number: NCT01124266

Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy

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).

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Key information

Conditions

Polyp Adenoma Adenomatous Polyp Adenomatous Polyps Colonoscopy Disease Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dankook University Hospital, Cheonan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard of care colonoscopy

Procedure

Single inspection by endoscopist during colonoscopy

Primary outcomes

  1. adenoma detection rate

    Time frame: 1 year

Secondary outcomes

  1. subjects with at least one polyp

    Time frame: 1 year

  2. Subjects with at least one adenoma

    Time frame: 1 year

  3. total number of polyp

    Time frame: 1 year

  4. total number of adenoma

    Time frame: 1 year

  5. Subjects with at least one advanced adenoma or cancer

    Time frame: 1 year

  6. total number of advanced adenoma or cancer

    Time frame: 1 year

  7. polyp and adenoma detection rate according to the endoscopists or nurse experience

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Soon Chun Hyang University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 17, 2010
Registry last updated
Feb 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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