Dynamic Position Change in Colonic Adenoma Detection
Primary Purpose
Position, Colonoscopy, Adenoma
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Position change
Left lateral
Sponsored by
About this trial
This is an interventional diagnostic trial for Position
Eligibility 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
Sites / Locations
- Catholic University of Korea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Position change
Left lateral
Arm Description
Position change group
Left lateral position
Outcomes
Primary Outcome Measures
Adenoma detection
Secondary Outcome Measures
Full Information
NCT ID
NCT01366079
First Posted
June 1, 2011
Last Updated
March 30, 2015
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT01366079
Brief Title
Dynamic Position Change in Colonic Adenoma Detection
Official Title
Dynamic Position Change in Colonic Adenoma Detection: a Prospective, Randomized, Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Position, Colonoscopy, Adenoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1072 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Position change
Arm Type
Experimental
Arm Description
Position change group
Arm Title
Left lateral
Arm Type
Active Comparator
Arm Description
Left lateral position
Intervention Type
Procedure
Intervention Name(s)
Position change
Intervention Description
Patients change position (cecum to hepatic flexure, left lateral; transverse colon, supine; splenic flexure and descending colon , right lateral) during colonoscopy withdrawal.
Intervention Type
Procedure
Intervention Name(s)
Left lateral
Intervention Description
In left lateral position group patients are positioned left lateral decubitus during colonoscopy withdrawal.
Primary Outcome Measure Information:
Title
Adenoma detection
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Catholic University of Korea
City
Incheon, Daejeon, Bucheon, Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Dynamic Position Change in Colonic Adenoma Detection
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