Effect of Single Colonoscopy on Colorectal Adenomas Detec... | NCT02693886

Studies
Effect of Single Colonoscopy on Colorectal Adenomas Detection

NCT02693886

Sponsor

Wuxi People's Hospital

Status

Unknown status

Last Update Posted

Feb 29, 2016Estimated

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Colonic Polyps

Interventions

doctor experience

Countries

Not provided

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

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Jan 27, 2016

First Submission Date that Met QC Criteria

Feb 26, 2016

First Posted Date

Feb 29, 2016Estimated

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

Feb 26, 2016

Last Update Posted Date

Feb 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Individualized colonoscopy withdrawal time is determined based on the different grade of physician experience and quality of bowel preparation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
A group	Experience of endoscopist: >2000 cases	Other: doctor experience
B group	Experience of endoscopist:between 1000 and 2000 cases	Other: doctor experience
C group	Experience of endoscopist:between 500 and 1000 cases	Other: doctor experience
D group	Experience of endoscopist:<500 cases	Other: doctor experience

Interventions

Name	Type	Description	Arm Group Labels	Other Names
doctor experience	Other		A group B group C group D group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection rate of polyps in different withdraw time		through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
Detection rate of polyps in different experiment levels of examiners		through study completion, an average of 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Greater than the age of 40;
Pathology and endoscopic data recorded available and detailed;
Whole bowel staining endoscopy is not done.

Exclusion Criteria:

Not reach the ileocecal junction;
Colorectal cancer;
Familial adenomatous polyposis;
Inflammatory bowel disease;
Part of the bowel resection.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

greater than the age of 40;
Pathology and endoscopic data recorded available and detailed;
Whole bowel staining endoscopy is not done.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003111	Colonic Polyps

Ancestor Terms

ID	Term
D007417	Intestinal Polyps
D011127	Polyps
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided