Ventral HerniaNCT01589276
Risk Factors and Results of Emergency Ventral Hernia Repair
An observational study of Ventral Hernia, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The aim of present study was to evaluate the clinical course after emergency ventral hernia repair in terms of 30-day-readmission, -reoperation and -mortality and to identify risk factors for emergency repair. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia
- How many people
- 10,976 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2007to Feb 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hernia repairs registered in the Danish Ventral Hernia Database during the study period
Who may be able to join
- All incisional, umblilical and epigastric hernia repiars
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of present study was to evaluate the clinical course after emergency ventral hernia repair in terms of 30-day-readmission, -reoperation and -mortality and to identify risk factors for emergency repair.
Read the detailed description
All incisional, umbilical and epigastric hernias registered in the Danish Ventral Hernia Database
- 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 |
|---|---|---|
| Emergency hernia repairs | Not described | |
| Elective hernia repairs | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk factors for emergency ventral hernia repair
evaluation of risk factors (hernia size, hernia type, type of surgery, age and gender) for poor outcome after emergency ventral hernia repair.
Measured: 4 years
Secondary outcomes (3)
30-day readmission
evaluation of risk factors (hernia size, hernia type, type of surgery, age and gender) for 30-day readmission after emergency ventral hernia repair
Measured: 30 days
30-day reoperation
evaluation of risk factors (hernia size, hernia type, type of surgery, age and gender) for 30-day reaoperation after emergency ventral hernia repair
Measured: 30 day
30-day mortality
evaluation of risk factors (hernia size, hernia type, type of surgery, age and gender) for 30-day mortality after emergency ventral hernia repair
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startJan 2007
- Primary completionJan 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10,976 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 sygehus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589276
- Sponsor's protocol ID
- FH08
- Status last verified
- Jun 2018
- First submitted
- 26 Apr 2012
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Helgstrand F, Rosenberg J, Kehlet H, Bisgaard T. Outcomes after emergency versus elective ventral hernia repair: a prospective nationwide study. World J Surg. 2013 Oct;37(10):2273-9. doi: 10.1007/s00268-013-2123-5.
PubMed 23756775
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 Results of Emergency Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT01589276
- Acronym / sponsor ID
- FH08
- Conditions
- Ventral Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,976 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 1 May 2012 (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 present study was to evaluate the clinical course after emergency ventral hernia repair in terms of 30-day-readmission, -reoperation and -mortality and to identify risk factors for emergency repair.
Detailed description
All incisional, umbilical and epigastric hernias registered in the Danish Ventral Hernia Database
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency hernia repairs | – | – |
| Elective hernia repairs | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hernia repairs registered in the Danish Ventral Hernia Database during the study period
Key inclusion criteria (1 listed)
- All incisional, umblilical and epigastric hernia repiars
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
risk factors for emergency ventral hernia repair
Time frame: 4 years
evaluation of risk factors (hernia size, hernia type, type of surgery, age and gender) for poor outcome after emergency ventral hernia repair.
3 secondary outcomes
30-day readmission
Time frame: 30 days
30-day reoperation
Time frame: 30 day
30-day mortality
Time frame: 30 day
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.
- Derived from this study: PubMed 23756775Helgstrand F, Rosenberg J, Kehlet H, Bisgaard T. Outcomes after emergency versus elective ventral hernia repair: a prospective nationwide study. World J Surg. 2013 Oct;37(10):2273-9. doi: 10.1007/s00268-013-2123-5.
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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.
Frederik Helgstrand, MD principal investigator
dept. surgery, Køge sygehus, Denmark
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 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?
risk factors for emergency ventral hernia repair (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01589276, which also lists 1 linked publication.
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.