Ventral HerniaNCT02292264
Risk Factors and Complications of Ventral Hernia Repair
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 risk factors and complications of ventral hernia repair. A retrospective study of journal files with patients undergoing ventral hernia repair, and an analyses of complications by use of the Clavien-Dindo classification of surgical complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- How many people
- 575 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent ventral hernia repair at the Surgical Department of Køge University Hospital in the timeperiod from 2009 - 2014.
Who may be able to join
- Surgically treated ventral hernia repair
Who cannot join
- All surgically treated patients are included
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate risk factors and complications of ventral hernia repair. A retrospective study of journal files with patients undergoing ventral hernia repair, and an analyses of complications by use of the Clavien-Dindo classification of surgical complications.
- 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 |
|---|---|---|
| Surgical treatment of ventral hernia | Adult patients who underwent a ventral hernia Repair at Zealand University hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying pre-operative risk factors by use of the Clavien Dindo classification.
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 posted17 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 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.
- 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
- 575 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
- Henrik Sjølander, MS, Principal investigator, Dept. of surgery, Køge University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292264
- Sponsor's protocol ID
- HS_01
- Status last verified
- Jun 2018
- First submitted
- 12 Nov 2014
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Complications of Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT02292264
- Acronym / sponsor ID
- HS_01
- Conditions
- Ventral Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Nov 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 risk factors and complications of ventral hernia repair. A retrospective study of journal files with patients undergoing ventral hernia repair, and an analyses of complications by use of the Clavien-Dindo classification of surgical complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment of ventral hernia | – | –Adult patients who underwent a ventral hernia Repair at Zealand University hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent ventral hernia repair at the Surgical Department of Køge University Hospital in the timeperiod from 2009 - 2014.
Key inclusion criteria (1 listed)
- Surgically treated ventral hernia repair
Key exclusion criteria (1 listed)
- All surgically treated patients are included
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
Identifying pre-operative risk factors by use of the Clavien Dindo classification.
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 27 Jun 2018.
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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.
Henrik Sjølander, MS principal investigator
Dept. of surgery, Køge University 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 1 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 27 Jun 2018. 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?
Identifying pre-operative risk factors by use of the Clavien Dindo classification. (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 27 Jun 2018.