Dynamic Position Change in Colonic Adenoma Detection

Colonoscopy Clinical Trial

Official title:

Dynamic Position Change in Colonic Adenoma Detection: a Prospective, Randomized, Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366079
• Other study ID #: Dynamic study
• Status: Completed
• Phase: N/A
• First received: June 1, 2011
• Last updated: March 30, 2015
• Start date: July 2011
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1072
• Est. completion date: March 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenoma
• Colonoscopy
• Position

Intervention

Procedure:
• Position change
Patients change position (cecum to hepatic flexure, left lateral; transverse colon, supine; splenic flexure and descending colon , right lateral) during colonoscopy withdrawal.
• Left lateral
In left lateral position group patients are positioned left lateral decubitus during colonoscopy withdrawal.

Locations

Country	Name	City	State
Korea, Republic of	Catholic University of Korea	Incheon, Daejeon, Bucheon, Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection		4 weeks	No