NCT01827410

Brief Summary

Is there agreement between data in the Danish Ventral Hernia Database and patient files

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

April 4, 2013

Last Update Submit

July 12, 2023

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Data agreement

    Compare information registered in The Danish Ventral Hernia Database with information obtained from patient files

    1 year

Study Arms (1)

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

Ventral hernia repairPROCEDURE
patients with a ventral hernia repair

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All ventral hernia repairs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Surgery, Køge Hospital

Køge, 4600, Denmark

Location

Study Officials

  • Frederik Helgstrand, MD

    Dept. Surgery, Køge Hospital, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 4, 2013

First Posted

April 9, 2013

Study Start

October 1, 2010

Primary Completion

October 1, 2011

Study Completion

February 1, 2013

Last Updated

July 13, 2023

Record last verified: 2023-07

Locations

DK(1)