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Dynamic Position Change in Colonic Adenoma Detection

This study is not yet open for participant recruitment.
Verified June 2011 by The Catholic University of Korea
Sponsor:
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01366079
First received: June 1, 2011
Last updated: June 2, 2011
Last verified: June 2011
History of Changes
  Purpose

There was an only single operator study reporting dynamic position change during colonoscopy withdrawal significantly improved polyp and adenoma detection. So we designed a prospective, randomized multicenter study to verify the effect of dynamic position change in colonic adenoma detection. We think position change improve luminal distension and has the potential to improve adenoma detection rate.


Condition Intervention
Position
Colonoscopy
Adenoma
 Procedure: Position change
Procedure: Left lateral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Dynamic Position Change in Colonic Adenoma Detection: a Prospective, Randomized, Multicenter Study

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Adenoma detection [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: July 2011
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Position change
Position change group
 Procedure: Position change
Patients change position (cecum to hepatic flexure, left lateral; transverse colon, supine; splenic flexure and descending colon , right lateral) during colonoscopy withdrawl.
Active Comparator: Left lateral
Left lateral position
 Procedure: Left lateral
In left lateral position group patients are positioned left lateral decubitus during colonoscopy withdrawal.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient aged over 45 years who will be performed colonoscopy for the first time

Exclusion Criteria:

  • polyposis syndrome
  • musculoskeletal problem
  • Inflammatory bowel disease
  • previous bowel operation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366079

Contacts
Contact: Jeong-Seon Ji, Dr +82-32-820-5052 jjsdr@catholic.ac.kr

Sponsors and Collaborators
The Catholic University of Korea
  More Information

No publications provided

Responsible Party: Jin Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01366079     History of Changes
Other Study ID Numbers: Dynamic study
Study First Received: June 1, 2011
Last Updated: June 2, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013