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Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy

S

Soon Chun Hyang University

Status and phase

Completed
Phase 4

Conditions

Adenomatous Polyp
Colonoscopy
Polyp

Treatments

Procedure: standard of care colonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT01124266
2010-15

Details and patient eligibility

About

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).

Enrollment

844 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

844 participants in 2 patient groups

endoscopist only
Experimental group
Treatment:
Procedure: standard of care colonoscopy
Procedure: standard of care colonoscopy
nurse participation
Experimental group
Treatment:
Procedure: standard of care colonoscopy
Procedure: standard of care colonoscopy

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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