Dynamic Position Change in Colonic Adenoma Detection | NCT01366079

Studies
Dynamic Position Change in Colonic Adenoma Detection

NCT01366079

Sponsor

The Catholic University of Korea

Status

Completed

Last Update Posted

Mar 31, 2015Estimated

Enrollment

1,072Actual

Phase

Not Applicable

Conditions

Position
Colonoscopy
Adenoma

Interventions

Position change
Left lateral

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2015Actual

First Submitted Date

Jun 1, 2011

First Submission Date that Met QC Criteria

Jun 2, 2011

First Posted Date

Jun 3, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2015

Last Update Posted Date

Mar 31, 2015Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,072Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Position change	Experimental	Position change group	Procedure: Position change
Left lateral	Active Comparator	Left lateral position	Procedure: Left lateral

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Position change	Procedure	Patients change position (cecum to hepatic flexure, left lateral; transverse colon, supine; splenic flexure and descending colon , right lateral) during colonoscopy withdrawal.

Measure	Description	Time Frame
Adenoma detection		4 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catholic University of Korea		Incheon, Daejeon, Bucheon, Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000236	Adenoma

Ancestor Terms

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

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Browse Branches

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