Correlation Between ADR of Screening and All Colonoscopies | NCT03730441

Studies
Correlation Between ADR of Screening and All Colonoscopies

NCT03730441

Sponsor

Hospital Frydek-Mistek

Status

Completed

Last Update Posted

Nov 5, 2018Actual

Enrollment

6,925Actual

Phase

Not provided

Conditions

Colon Neoplasm

Interventions

Colonoscopy

Countries

Czechia

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

Nov 2018

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 2013Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Nov 2, 2018

First Submission Date that Met QC Criteria

Nov 2, 2018

First Posted Date

Nov 5, 2018Actual

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

Nov 2, 2018

Last Update Posted Date

Nov 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 aim of the study is to compare ADR for colonoscopies from various indications and to find correlations between ADR of screening and all examinations.

Detailed Description

ADR (adenoma detection rate) is generally accepted quality indicator and it is calculated from screening colonoscopies in patients over 50 years of age. For possible gaming with ADR for screening colonoscopies, monitoring of ADR for all colonoscopies is discussed nowadays.The aim of the study is to compare ADR for colonoscopies from various indications and to find correlations between ADR of screening and all examinations.

We want to retrospectively assess the quality indicators of all colonoscopies performed from January 2013 to December 2017. We want to calculate ADR for all colonoscopies in patients over 50 years of age excluding therapeutic, IBD, management of complications and sigmoidoscopies (screening, surveillance, diagnostic) and separately only for screening colonoscopies. Correlation analysis will be performed using Pearson´s correlation coefficient.

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

6,925Actual

Name	Type	Description	Arm Group Labels	Other Names
Colonoscopy	Device	Endoscopic examination of large bowel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation between ADR of screening and all colonoscopies (screening, surveillance, diagnostic)	Pearson´s correlation coefficient	january 2013 - december 2017

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

people over 50 years of age coming for colonoscopic examination (screening, surveillance, diagnostic)

Exclusion Criteria:

age under 50 years
indication for colonoscopy: therapeutic, IBD, management of complications and sigmoidoscopies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

people over 50 years of age coming for colonoscopic examination

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ivana Mikoviny Kajzrlikova	Doctor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Frydek-Mistek		Frýdek-Místek			Czechia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33325459	Derived	Mikoviny Kajzrlikova I, Vitek P, Chalupa J, Kuchar J, Platos J, Reha P, Klvana P. Correlation between ADR of screening and all colonoscopies. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2021 Nov;165(4):386-389. doi: 10.5507/bp.2020.059. Epub 2020 Dec 16.

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

ID	Term
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures