NCT01366079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,072

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

2.7 years

First QC Date

June 1, 2011

Last Update Submit

March 30, 2015

Conditions

PositionColonoscopyAdenoma

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection

    4 weeks

Study Arms (2)

Position change

EXPERIMENTAL

Position change group

Procedure: Position change

Left lateral

ACTIVE COMPARATOR

Left lateral position

Procedure: Left lateral

Interventions

Position changePROCEDURE

Patients change position (cecum to hepatic flexure, left lateral; transverse colon, supine; splenic flexure and descending colon , right lateral) during colonoscopy withdrawal.

Position change
Left lateralPROCEDURE

In left lateral position group patients are positioned left lateral decubitus during colonoscopy withdrawal.

Left lateral

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • polyposis syndrome
  • musculoskeletal problem
  • Inflammatory bowel disease
  • previous bowel operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Korea

Incheon, Daejeon, Bucheon, Seoul, South Korea

Location

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 3, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2015

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

KR(1)