Dynamic Position Change in Colonic Adenoma Detection

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

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.

Study Overview

• Status: Completed
• Conditions: Adenoma; Colonoscopy; Position
• Intervention / Treatment: Procedure: Position change; Procedure: Left lateral

• Study Type: Interventional
• Enrollment (Actual): 1072
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Daejeon, Bucheon, Seoul, Korea, Republic of
    • Catholic University of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 withdrawal.
Active Comparator: Left lateral; Left lateral position	Procedure: Left lateral; In left lateral position group patients are positioned left lateral decubitus during colonoscopy withdrawal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adenoma detection	4 weeks

Collaborators and Investigators

• Sponsor: The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: June 1, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): March 31, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: Dynamic study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No