Epigastric HerniaEPI-WOMENNCT05750368
Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study
An observational study of Epigastric Hernia and Women With Epigastric Hernias, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The aim was to evaluate outcomes after epigastric hernia repair in women on a nationwide basis. The primary outcome iss recurrence - secondary outcomes are readmission, operation for complication, risk factors for recurrence, and readmittance. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Epigastric Hernia, Women With Epigastric Hernias
- How many people
- 3,031 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2022to 1 Feb 2023
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: all patients undergoing ventral hernia repair in Denmark.
Who may be able to join
- All female patients undergoing elective repair with a laparoscopic or open technique for an epigastric hernia were included.
Who cannot join
- umbilical or incisional hernias, male patients, recurrent hernia repairs, and hernia repairs performed in relation to other surgical procedures.
Trial locations and contacts
1 site in 1 country.
About this study
The aim was to evaluate outcomes after epigastric hernia repair in women on a nationwide basis. The primary outcome iss recurrence - secondary outcomes are readmission, operation for complication, risk factors for recurrence, and readmittance.
Read the detailed description
Aim Outcomes after epigastric hernia repair are rarely reported independently. Furthermore, women have the highest prevalence of epigastric hernia repair in the age of 41-50 years.
The aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in women on a nationwide basis.
Methods Nationwide database cohort study using prospectively recorded data from the Danish Hernia Database from women undergoing elective repair for epigastric hernias, during a 4-year period (2018-2021). A 100% follow-up was obtained by combining intra-operative data with data from the National Civil Register (NRC). The primary outcome was operation for recurrence, secondary outcomes were readmission and operation for complications. We compared open vs. laparoscopic repairs, and subgroup analysis were made for open repairs (sutured vs. mesh).
- Conditions
- Epigastric Hernia, Women With Epigastric Hernias
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 |
|---|---|---|
| women undergoing epigastric hernia repair | all women who have undergone epigastric hernia repair open or laparoscopic in Denmark during af 4-year period from January 1st, 2018, to Dec 31st, 2021. |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation for recurrence
operation for recurrence during the observation period
Measured: 4 year
Secondary outcomes (2)
Readmittance
readmittance within 90 days after repair
Measured: 90 days
operation for complications
90 days operation for complications
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Sep 2022
- Primary completion1 Jan 2023
- Study completion1 Feb 2023
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
- Retrospective
- Enrolment
- 3,031 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital
- Responsible party
- Principal investigator, Mette Willaume, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750368
- Sponsor's protocol ID
- women-epigastric
- Acronym
- EPI-WOMEN
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 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
- NCT05750368
- Acronym / sponsor ID
- EPI-WOMEN / women-epigastric
- Conditions
- Epigastric Hernia, Women With Epigastric Hernias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,031 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Herlev Hospital
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 1 Mar 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.
The aim was to evaluate outcomes after epigastric hernia repair in women on a nationwide basis. The primary outcome iss recurrence - secondary outcomes are readmission, operation for complication, risk factors for recurrence, and readmittance.
Detailed description
Aim Outcomes after epigastric hernia repair are rarely reported independently. Furthermore, women have the highest prevalence of epigastric hernia repair in the age of 41-50 years.
The aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in women on a nationwide basis.
Methods Nationwide database cohort study using prospectively recorded data from the Danish Hernia Database from women undergoing elective repair for epigastric hernias, during a 4-year period (2018-2021). A 100% follow-up was obtained by combining intra-operative data with data from the National Civil Register (NRC). The primary outcome was operation for recurrence, secondary outcomes were readmission and operation for complications. We compared open vs. laparoscopic repairs, and subgroup analysis were made for open repairs (sutured vs. mesh).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women undergoing epigastric hernia repair | – | –all women who have undergone epigastric hernia repair open or laparoscopic in Denmark during af 4-year period from January 1st, 2018, to Dec 31st, 2021. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients undergoing ventral hernia repair in Denmark.
Key inclusion criteria (1 listed)
- All female patients undergoing elective repair with a laparoscopic or open technique for an epigastric hernia were included.
Key exclusion criteria (1 listed)
- umbilical or incisional hernias, male patients, recurrent hernia repairs, and hernia repairs performed in relation to other surgical procedures.
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 recurrence
Time frame: 4 year
operation for recurrence during the observation period
2 secondary outcomes
Readmittance
Time frame: 90 days
operation for complications
Time frame: 90 days
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 7 Mar 2023.
- Individual participant dataSharing planned: No
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 and Women With Epigastric Hernias, 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 7 Mar 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?
operation for recurrence (time frame: 4 year). 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 7 Mar 2023.