Recurrent Hernia of Anterior Abdominal WallNCT02564757
Does Pregnancy Increase Risk of Ventral Hernia Recurrence?
An observational study of Recurrent Hernia of Anterior Abdominal Wall, run by Bispebjerg Hospital.
Trial summary
The investigators will examine if pregnancy increases risk of ventral hernia recurrence Read more about this study
- Who is it for?
- Ages 12 to 45 years, women only
- Conditions the study is for
- Recurrent Hernia of Anterior Abdominal Wall
- How many people
- 3,578 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to May 2016
- 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 12 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Fertile female patients who have undergone ventral hernia repair
Who may be able to join
- Fertile female patient
Who cannot join
- non-Danish citizen
About this study
The investigators will examine if pregnancy increases risk of ventral hernia recurrence
Read the detailed description
The investigators will establish a cohort of female fertile patients who underwent ventral hernia repair (Umbilical, Epigastric and Incisional hernia repair) registered in the Danish Hernia Database. The investigators will link these data at an individual level with the Danish National Patient Registry (DNPR), Danish Medical Birth Registry (DMBR) and the Danish Civil Registry (CPR).
From DMBR, subsequent pregnancies in the study cohort will be noted. From DNPR, ventral hernia recurrence, defined as clinical recurrence and/or reoperation for recurrence will be noted. Cases registered with both clinical recurrence and reoperation for recurrence, the date of the earliest registration will be defined as the date of ventral hernia recurrence.
From CPR, date of death or emigration will be noted.
Through an extended Cox regression analysis, handling pregnancy as a time-dependent variable, the investigators will examine whether pregnancy is associated with an increased risk of ventral hernia recurrence.
- Medical subject headings
- Hernia, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence
Clinical ventral hernia recurrence will be defined as clinical recurrence retrieved from the Danish National Patient Registry.
Measured: 0-7 years
Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence Repair
Ventral hernia recurrence repair will be defined as reoperation retrieved from the Danish National Patient Registry.
Measured: 0-8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Hernia of Anterior Abdominal WallStudies 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
- 3,578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Erling Oma, Bispebjerg Hospital
- Investigators
- Lars N Jorgensen, MD, DMSc, Study chair, Bispebjerg Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564757
- Sponsor's protocol ID
- eoma2
- Status last verified
- Jan 2017
- First submitted
- 29 Sep 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pregnancy Increase Risk of Ventral Hernia Recurrence?
- ClinicalTrials.gov ID
- NCT02564757
- Acronym / sponsor ID
- eoma2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,578 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Oct 2015 (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 investigators will examine if pregnancy increases risk of ventral hernia recurrence
Detailed description
The investigators will establish a cohort of female fertile patients who underwent ventral hernia repair (Umbilical, Epigastric and Incisional hernia repair) registered in the Danish Hernia Database. The investigators will link these data at an individual level with the Danish National Patient Registry (DNPR), Danish Medical Birth Registry (DMBR) and the Danish Civil Registry (CPR).
From DMBR, subsequent pregnancies in the study cohort will be noted. From DNPR, ventral hernia recurrence, defined as clinical recurrence and/or reoperation for recurrence will be noted. Cases registered with both clinical recurrence and reoperation for recurrence, the date of the earliest registration will be defined as the date of ventral hernia recurrence.
From CPR, date of death or emigration will be noted.
Through an extended Cox regression analysis, handling pregnancy as a time-dependent variable, the investigators will examine whether pregnancy is associated with an increased risk of ventral hernia recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Fertile female patients who have undergone ventral hernia repair
Key inclusion criteria (1 listed)
- Fertile female patient
Key exclusion criteria (1 listed)
- non-Danish citizen
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
Clinical Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence
Time frame: 0-7 years
Clinical ventral hernia recurrence will be defined as clinical recurrence retrieved from the Danish National Patient Registry.
Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence Repair
Time frame: 0-8 years
Ventral hernia recurrence repair will be defined as reoperation retrieved from the Danish National Patient Registry.
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 31 Jan 2017.
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.
Lars N Jorgensen, MD, DMSc study chair
Bispebjerg Hospital, University of Copenhagen
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Hernia of Anterior Abdominal Wall, run by Bispebjerg Hospital.
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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence (time frame: 0-7 years). The study lists 2 primary outcomes in all. 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 31 Jan 2017; AzTrials last refreshed its copy on 3 Nov 2026.