High Agreement Between the Danish Ventral Hernia Database... | NCT01827410

Studies
High Agreement Between the Danish Ventral Hernia Database and Hospital Files in Region Zealand

NCT01827410

Sponsor

Zealand University Hospital

Status

Completed

Last Update Posted

Jul 13, 2023Actual

Enrollment

408Actual

Phase

Not provided

Conditions

Data Agreement Between a Database and Hospital Files After a Ventral Hernia Repair

Interventions

Ventral hernia repair

Countries

Denmark

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

Jul 2023

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

Oct 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Feb 2013Actual

First Submitted Date

Apr 4, 2013

First Submission Date that Met QC Criteria

Apr 8, 2013

First Posted Date

Apr 9, 2013Estimated

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

Jul 12, 2023

Last Update Posted Date

Jul 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

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

408Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with a ventral hernia repair		All patients with a ventral hernia repair performed in Region Zealand and registered in The Danish Ventral Hernia Database during October 1st 2010 to October 1st 2011	Procedure: Ventral hernia repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ventral hernia repair	Procedure		patients with a ventral hernia repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Data agreement	Compare information registered in The Danish Ventral Hernia Database with information obtained from patient files	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All ventral hernia repairs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Hernia repairs performed in Region Zealand and registered in the Danish Ventral Hernia Database during the study period

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederik Helgstrand, MD	Dept. Surgery, Køge Hospital, University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Surgery, Køge Hospital		Køge		4600	Denmark