Ventral HerniaNCT02263599
Conservative Treatment For Ventral Hernia
An observational study of Ventral Hernia, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to evaluate on which indication patients are offered operative treatment for their ventral hernia, and to investigate the natural course of ventral hernia in the population of patients not offered operation. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Ventral Hernia
- How many people
- 2,089 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Apr 2015
- 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: All patients referred to the Surgical Department of Køge University Hospital in the timeperiod from 2009 - 2014 with the diagnosis ventral hernia
Who may be able to join
- All patients (older than 18 years) referred to the Surgical Department of Køge University Hospital from 2009 - 2014 with the diagnosis ventral hernia
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate on which indication patients are offered operative treatment for their ventral hernia, and to investigate the natural course of ventral hernia in the population of patients not offered operation.
- Conditions
- Ventral Hernia
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conservatively treated ventral hernias | Not described | |
| Surgically treated ventral hernias | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of conservatively treated ventral hernias that undergo surgery
Percentage of conservatively treated ventral hernias at the primary surgical consultation, that undergoes surgery (acute or elective) later on
Measured: 5 years
Secondary outcomes (1)
Percentage of patient with ventral hernia that are treated conservatively
Percentage of patient referred to Køge Surgical Department with ventral hernia that are treated conservatively instead of surgically
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 2,089 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
- Dunja Kokotovic, MS, Principal investigator, Dept. of Surgery, Køge Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263599
- Sponsor's protocol ID
- DK_01
- Status last verified
- Jul 2023
- First submitted
- 20 Sep 2014
- 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
- Conservative Treatment For Ventral Hernia
- ClinicalTrials.gov ID
- NCT02263599
- Acronym / sponsor ID
- DK_01
- Conditions
- Ventral Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,089 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Oct 2014 (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.
The aim of this study is to evaluate on which indication patients are offered operative treatment for their ventral hernia, and to investigate the natural course of ventral hernia in the population of patients not offered operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservatively treated ventral hernias | – | – |
| Surgically treated ventral hernias | – | – |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to the Surgical Department of Køge University Hospital in the timeperiod from 2009 - 2014 with the diagnosis ventral hernia
Key inclusion criteria (1 listed)
- All patients (older than 18 years) referred to the Surgical Department of Køge University Hospital from 2009 - 2014 with the diagnosis ventral hernia
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.
Primary outcome
Percentage of conservatively treated ventral hernias that undergo surgery
Time frame: 5 years
Percentage of conservatively treated ventral hernias at the primary surgical consultation, that undergoes surgery (acute or elective) later on
1 secondary outcome
Percentage of patient with ventral hernia that are treated conservatively
Time frame: 5 years
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.
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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.
Dunja Kokotovic, MS principal investigator
Dept. of Surgery, Køge Hospital
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 Ventral Hernia, 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?
Percentage of conservatively treated ventral hernias that undergo surgery (time frame: 5 years). 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; AzTrials last refreshed its copy on 30 Oct 2026.