Umbilical HerniaNCT06783036
Long-term Recurrence and Other Complications Requiring Surgery Following Primary Ventral Hernia Repair
An observational study of Umbilical Hernia and Epigastric Hernia, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Nationwide, registry based cohort studies on all complications requiring surgery following primary ventral hernia repair Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Umbilical Hernia, Epigastric Hernia
- How many people
- 7,200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2024to 31 Dec 2025
- 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: Nationwide population of patients registered in the Danish Ventral Hernia Database
Who may be able to join
- Operation for primary ventral hernia repair registered in Danish Ventral Hernia Database
- Known body mass index and smoking status at time of surgery, as registered in the Danish Ventral Hernia Database
Who cannot join
- Hernia type misclassification (based on manual medical file review)
Trial locations and contacts
1 site in 1 country.
About this study
Nationwide, registry based cohort studies on all complications requiring surgery following primary ventral hernia repair
Read the detailed description
Cohort based on patients registered in the Danish Ventral Hernia Database. Through cross-linking at an individual level, all subsequent operations will be identified in the Danish National Patient Registry. For all potentially related reoperations, patient charts will be retrieved and manually reviewed. Furthermore cross-linkage with the Danish Civil Registration System to retrieve information on civil status. Follow up from time of operation for primary ventral hernia repair (index operation) until reoperation, death, emigration or end of follow up (December 31, 2023), whichever comes first.
- Conditions
- Umbilical Hernia, Epigastric Hernia
- Medical subject headings
- Hernia, Umbilical
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 umbilical hernia repair | no study intervention | |
| Elective umbilical hernia repair | no study intervention | |
| Emergency epigastric hernia repair | no study intervention | |
| Elective epigastric hernia repair | no study intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation for hernia recurrence
Measured: Until december 31, 2023
Secondary outcomes (1)
Operation for non-recurrence complication
Measured: Until december 31, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Feb 2024
- Primary completion1 Nov 2024
- Study completion31 Dec 2025
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 Umbilical 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
- Retrospective
- Enrolment
- 7,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erling Oma, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783036
- Sponsor's protocol ID
- P-2023-193
- Other IDs
- R-23045342, DHDB-2023-04-03, FSEID-00006723
- Status last verified
- Sep 2026
- First submitted
- 14 Jan 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fredberg J, Oma E, Brandenburger N, Oztoprak M, Helgstrand F, Jorgensen LN. Repair of elective epigastric hernias in adults: nationwide registry study of short- and long-term complications requiring reoperation. Hernia. 2026 Oct 22;30(1):383. doi: 10.1007/s10029-026-03884-4.
PubMed 42911421
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Recurrence and Other Complications Requiring Surgery Following Primary Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT06783036
- Acronym / sponsor ID
- P-2023-193
- Conditions
- Umbilical Hernia, Epigastric Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,200 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 Jan 2025 (actual)
- 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.
Nationwide, registry based cohort studies on all complications requiring surgery following primary ventral hernia repair
Detailed description
Cohort based on patients registered in the Danish Ventral Hernia Database. Through cross-linking at an individual level, all subsequent operations will be identified in the Danish National Patient Registry. For all potentially related reoperations, patient charts will be retrieved and manually reviewed. Furthermore cross-linkage with the Danish Civil Registration System to retrieve information on civil status. Follow up from time of operation for primary ventral hernia repair (index operation) until reoperation, death, emigration or end of follow up (December 31, 2023), whichever comes first.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Emergency umbilical hernia repair | – | –no study intervention |
| Elective umbilical hernia repair | – | –no study intervention |
| Emergency epigastric hernia repair | – | –no study intervention |
| Elective epigastric hernia repair | – | –no study intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nationwide population of patients registered in the Danish Ventral Hernia Database
Key inclusion criteria (2 listed)
- Operation for primary ventral hernia repair registered in Danish Ventral Hernia Database
- Known body mass index and smoking status at time of surgery, as registered in the Danish Ventral Hernia Database
Key exclusion criteria (1 listed)
- Hernia type misclassification (based on manual medical file review)
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
Operation for hernia recurrence
Time frame: Until december 31, 2023
1 secondary outcome
Operation for non-recurrence complication
Time frame: Until december 31, 2023
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 1 Oct 2026.
- Derived from this study: PubMed 42911421Fredberg J, Oma E, Brandenburger N, Oztoprak M, Helgstrand F, Jorgensen LN. Repair of elective epigastric hernias in adults: nationwide registry study of short- and long-term complications requiring reoperation. Hernia. 2026 Oct 22;30(1):383. doi: 10.1007/s10029-026-03884-4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Umbilical Hernia and Epigastric Hernia, run by Bispebjerg 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 2 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 1 Oct 2026. 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?
Operation for hernia recurrence (time frame: Until december 31, 2023). 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 NCT06783036, 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 1 Oct 2026.