The Factors Affecting ADR of Screening Colonoscopy | NCT04397120

Studies
The Factors Affecting ADR of Screening Colonoscopy

NCT04397120

Sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Status

Completed

Last Update Posted

May 21, 2020Actual

Enrollment

13,495Actual

Phase

Not provided

Conditions

Adenoma Detection Rate
Colonoscopy

Interventions

Not provided

Countries

China

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

May 2020

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

Jan 1, 2019Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Apr 30, 2020Actual

First Submitted Date

May 16, 2020

First Submission Date that Met QC Criteria

May 19, 2020

First Posted Date

May 21, 2020Actual

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

May 19, 2020

Last Update Posted Date

May 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

The purpose of this study is to assess the impact of multilevel factors on the quality of screening colonoscopy, reflected mainly by adenoma detection rate (ADR).

Detailed Description

The subjects will include patients who need to screening colonoscopies by 21 endoscopists between January 2019 and December 2019 were retrospectively enrolled in this unit. Multilevel factors, including patient-, proceduralist-, and procedure-level characteristics were analyzed for the relationship with ADR.

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

13,495Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adenoma detection rate	the proportion of colonoscopies in which at least one adenoma was detected	After histopathologically examined, reviewed, and confirmed, an average of 7 days.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients were retrospectively included in this study if they had undergone a completed colonoscopy.

Exclusion Criteria:

prior colonoscopy within 3 years;
medical history of inflammatory bowel disease (IBD), CRC, or abdominal surgery;
fair or poor quality of bowel preparation (fair quality: some semisolid stool that could be suctioned or washed away but >90% of mucosal surface seen; poor quality: semisolid stool that could not be suctioned or washed away with <90% of mucosal surface seen);
failure in cecal intubation;
withdrawal time without removing<6 min.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Endoscopy Department of a university Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bin Lu, M.D.	First Affiliated Hospital of Zhejiang Chinese Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of Zhejiang Chinese Medical University		Hangzhou	Zhejiang	310006	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Individual participant data sharing will be consider after study

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided