Hernia, VentralNCT02398565
Pregnancy Subsequent to Ventral Hernia Repair
An observational study of Hernia, Ventral and Pregnancy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
We will examine the outcome of ventral hernia repair with subsequent pregnancy Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Hernia, Ventral, Pregnancy
- How many people
- 7,612 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Oct 2015
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Nationwide study population of patients registered with a ventral hernia repair in The Danish Hernia Database between January 1 2007 and December 31 2014
Who may be able to join
- History of ventral hernia repair with subsequent pregnancy
- Born between January 1 1955 and January 1 1995
Who cannot join
- Registered in the Danish Hernia Database with a non-valid ID-number, i.e. non-Danish resident.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pregnancy Subsequent to Ventral Hernia Repair: a Nationwide Cohort Study
We will examine the outcome of ventral hernia repair with subsequent pregnancy
- Conditions
- Hernia, Ventral, Pregnancy
- Being tested
- No intervention
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Patients with a history of ventral hernia repair (umbilical/epigastric and incisional) with subsequent pregnancy
Ventral hernia repair - perioperative factors of interest:
- mesh vs sutured repair, age, planned vs emergency repair, open vs laparoscopic approach,
Pregnancy and delivery - factors of interest:
- vaginal vs caesearan section, single vs multiple pregnancy
Subgroup of patients with mesh repair:
- subanalysis on main attributes
Subgroup of patients with sutured repair:
- mono- vs multifilament, slowly vs rapidly absorbable Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of ventral hernia
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies 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
- 7,612 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, Study chair, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398565
- Sponsor's protocol ID
- BBH-2015-009
- Status last verified
- Jan 2016
- First submitted
- 19 Mar 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Subsequent to Ventral Hernia Repair: a Nationwide Cohort Study
- ClinicalTrials.gov ID
- NCT02398565
- Acronym / sponsor ID
- BBH-2015-009
- Conditions
- Hernia, Ventral, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,612 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Mar 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.
We will examine the outcome of ventral hernia repair with subsequent pregnancy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Other: No interventionPatients with a history of ventral hernia repair (umbilical/epigastric and incisional) with subsequent pregnancy Ventral hernia repair - perioperative factors of interest: - mesh vs sutured repair, age, planned vs emergency repair, open vs laparoscopic approach, Pregnancy and delivery - factors of interest: - vaginal vs caesearan section, single vs multiple pregnancy Subgroup of patients with mesh repair: - subanalysis on main attributes Subgroup of patients with sutured repair: - mono- vs multifilament, slowly vs rapidly absorbable |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Nationwide study population of patients registered with a ventral hernia repair in The Danish Hernia Database between January 1 2007 and December 31 2014
Key inclusion criteria (2 listed)
- History of ventral hernia repair with subsequent pregnancy
- Born between January 1 1955 and January 1 1995
Key exclusion criteria (1 listed)
- Registered in the Danish Hernia Database with a non-valid ID-number, i.e. non-Danish resident.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Cohort |
Primary outcome
Recurrence of ventral hernia
Time frame: 7 years
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 12 Jan 2016.
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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.
Lars N Jorgensen study chair
Bispebjerg Hospital
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 Hernia, Ventral and Pregnancy, 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 12 Jan 2016. 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?
Recurrence of ventral hernia (time frame: 7 years). 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 12 Jan 2016.