Data Agreement Between a Database and Hospital Files After a Ventral Hernia RepairNCT01827410
High Agreement Between the Danish Ventral Hernia Database and Hospital Files in Region Zealand
An observational study of Data Agreement Between a Database and Hospital Files After a Ventral Hernia Repair, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Is there agreement between data in the Danish Ventral Hernia Database and patient files Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Data Agreement Between a Database and Hospital Files After a Ventral Hernia Repair
- What is being tested?
- Ventral hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 408 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2010to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hernia repairs performed in Region Zealand and registered in the Danish Ventral Hernia Database during the study period
Who may be able to join
- All ventral hernia repairs
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Is there agreement between data in the Danish Ventral Hernia Database and patient files
- Being tested
- Ventral hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventral hernia repairProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Ventral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data agreement
Compare information registered in The Danish Ventral Hernia Database with information obtained from patient files
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startOct 2010
- Primary completionOct 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Data Agreement Between a Database and Hospital Files After a Ventral Hernia RepairStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederik Helgstrand, Zealand University Hospital
- Investigators
- Frederik Helgstrand, MD, Principal investigator, Dept. Surgery, Køge Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827410
- Sponsor's protocol ID
- FH10
- Status last verified
- Jul 2023
- First submitted
- 4 Apr 2013
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Agreement Between the Danish Ventral Hernia Database and Hospital Files in Region Zealand
- ClinicalTrials.gov ID
- NCT01827410
- Acronym / sponsor ID
- FH10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Is there agreement between data in the Danish Ventral Hernia Database and patient files
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with a ventral hernia repair | – | Procedure: Ventral hernia repairAll 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 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hernia repairs performed in Region Zealand and registered in the Danish Ventral Hernia Database during the study period
Key inclusion criteria (1 listed)
- All ventral hernia repairs
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventral hernia repair | Procedure or surgery | patients with a ventral hernia repair |
Primary outcome
Data agreement
Time frame: 1 year
Compare information registered in The Danish Ventral Hernia Database with information obtained from patient files
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederik Helgstrand, MD principal investigator
Dept. Surgery, Køge Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Data Agreement Between a Database and Hospital Files After a Ventral Hernia Repair, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data agreement (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.