Epigastric HerniaEPI-WOMENNCT06074146
Outcomes After Epigastric Hernia Repair in Women.
An observational study of Epigastric Hernia, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Nationwide cohort study on women undergoing epigastric hernia repair Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epigastric Hernia
- How many people
- 3,031 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2007to 1 Jan 2022
- How long will I take part?
- 5 Years
- 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 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: females in Denmark undergoing epigastric hernia repair
Who may be able to join
- females undergoing epigastric hernia repair in Denmark
Who cannot join
- emergency repair umbilical hernias incisional hernias males
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study
Nationwide cohort study on women undergoing epigastric hernia repair
Read the detailed description
Women have the highest prevalence of epigastric hernia repair. Outcomes after epigastric hernia repair are rarely reported independently, although pathology and surgical techniques may be different than for other primary ventral hernias.
The aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in women on a nationwide basis.
Methods Nationwide cohort study from the Danish Hernia Database. Complete data from women undergoing elective epigastric hernia repair during a 12-year period (2007-2018) was extracted. A 100% follow-up was obtained by combining data from the National Civil Register. The primary outcome was operation for recurrence, secondary outcomes were readmission and operation for complications. Outcomes for open sutured repair, open mesh repair mesh, and laparoscopic repairs were compared.
- Conditions
- Epigastric Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
hernia recurrence
reoperation for recurrence
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jan 2007
- Primary completion31 Dec 2018
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epigastric 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
- 3,031 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Willaume, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074146
- Sponsor's protocol ID
- EPI-WOMEN
- Acronym
- EPI-WOMEN
- Status last verified
- Oct 2023
- First submitted
- 4 Aug 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study
- ClinicalTrials.gov ID
- NCT06074146
- Acronym / sponsor ID
- EPI-WOMEN / EPI-WOMEN
- Conditions
- Epigastric Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,031 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 10 Oct 2023 (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 cohort study on women undergoing epigastric hernia repair
Detailed description
Women have the highest prevalence of epigastric hernia repair. Outcomes after epigastric hernia repair are rarely reported independently, although pathology and surgical techniques may be different than for other primary ventral hernias.
The aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in women on a nationwide basis.
Methods Nationwide cohort study from the Danish Hernia Database. Complete data from women undergoing elective epigastric hernia repair during a 12-year period (2007-2018) was extracted. A 100% follow-up was obtained by combining data from the National Civil Register. The primary outcome was operation for recurrence, secondary outcomes were readmission and operation for complications. Outcomes for open sutured repair, open mesh repair mesh, and laparoscopic repairs were compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- females in Denmark undergoing epigastric hernia repair
Key inclusion criteria (1 listed)
- females undergoing epigastric hernia repair in Denmark
Key exclusion criteria (1 listed)
- emergency repair umbilical hernias incisional hernias males
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
hernia recurrence
Time frame: end of study
reoperation for recurrence
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 10 Oct 2023.
Related trials for Epigastric Hernia
Recruiting
Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment
Abdominal Wall Hernia, Umbilical Hernia Repair
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 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 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 10 Oct 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?
hernia recurrence (time frame: end of study). 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 10 Oct 2023.