Ventral HerniaNCT01501682
Long Term Complaints After Elective Repair for Small Umbilical or Epigastric Hernias
An observational study of Ventral Hernia, run by Zealand University Hospital at 2 sites in Denmark.
Trial summary
The purpose of this study is to compare the long-term complaints after ventral hernia repair after insertion of different types of mesh compared with primary suture. Also recurrence of hernia will be discussed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- How many people
- 150 participants
- Where
- 2 sitesDenmark
- Study dates
- Feb 2011to Dec 2011
- 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: operated for ventral hernia from the year 2004 to the year 2009 at Koege Hospital
Who may be able to join
- operated for ventral hernia from the year 2004 to the year 2009
Who cannot join
- liver cirrhosis
- pregnancy
- combined hernia
- operation for ventral hernia and other operation
- laparoscopic operation
- acute operation
- recurrence of hernia
Trial locations and contacts
2 sites in 1 country.
Frederik helgstrand, MD contact
Thue Bisgaard contact
Denmark2 sites, 2 recruiting
- Recruiting
Koege hospital
Koege, 4600
Liv Erritzøe-Jervild, +4526182900, liver@stud.ku.dk
Frederik Helgstrand, M.D
- Recruiting
Køge sygehus
Køge, 4600
Frederik Helgstrand, MD, freh@regionsjaelland.dk
Frederik Helgstrand, MD
About this study
The purpose of this study is to compare the long-term complaints after ventral hernia repair after insertion of different types of mesh compared with primary suture. Also recurrence of hernia will be discussed.
Read the detailed description
The purpose of this study is to compare the long-term complaints after ventral hernia repair after insertion of different types of mesh compared with primary suture. Based on a questionnaire selected patients will be invited to clinical examination for recurrence and more detailed interview.
- Conditions
- Ventral Hernia
- Keywords
- ventralex, ventral hernia
- Medical subject headings
- Hernia, Ventral
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 |
|---|---|---|
| primary suture | operated with primary suture | |
| other mesh | operated with insertion of another mesh | |
| ventralex | operated with insertion of ventralex mesh |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
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 Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liv Erritzøe-Jervild, Zealand University Hospital
- Investigators
- Liv Erritzøe-Jervild, Principal investigator, Køge Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501682
- Sponsor's protocol ID
- ventralexmesh_KoegeHospital
- Status last verified
- Dec 2011
- First submitted
- 18 Dec 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Erritzoe-Jervild L, Christoffersen MW, Helgstrand F, Bisgaard T. Long-term complaints after elective repair for small umbilical or epigastric hernias. Hernia. 2013 Apr;17(2):211-5. doi: 10.1007/s10029-012-0960-z. Epub 2012 Jul 14.
PubMed 22797701
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Complaints After Elective Repair for Small Umbilical or Epigastric Hernias
- ClinicalTrials.gov ID
- NCT01501682
- Acronym / sponsor ID
- ventralexmesh_KoegeHospital
- Conditions
- Ventral Hernia
- Keywords
- ventralex, ventral hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 29 Dec 2011 (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 purpose of this study is to compare the long-term complaints after ventral hernia repair after insertion of different types of mesh compared with primary suture. Also recurrence of hernia will be discussed.
Detailed description
The purpose of this study is to compare the long-term complaints after ventral hernia repair after insertion of different types of mesh compared with primary suture. Based on a questionnaire selected patients will be invited to clinical examination for recurrence and more detailed interview.
Study design
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| primary suture | – | –operated with primary suture |
| other mesh | – | –operated with insertion of another mesh |
| ventralex | – | –operated with insertion of ventralex mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- operated for ventral hernia from the year 2004 to the year 2009 at Koege Hospital
Key inclusion criteria (1 listed)
- operated for ventral hernia from the year 2004 to the year 2009
Key exclusion criteria (7 listed)
- liver cirrhosis
- pregnancy
- combined hernia
- operation for ventral hernia and other operation
- laparoscopic operation
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
- Derived from this study: PubMed 22797701Erritzoe-Jervild L, Christoffersen MW, Helgstrand F, Bisgaard T. Long-term complaints after elective repair for small umbilical or epigastric hernias. Hernia. 2013 Apr;17(2):211-5. doi: 10.1007/s10029-012-0960-z. Epub 2012 Jul 14.
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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.
Frederik helgstrand, MD contact
Thue Bisgaard contact
Liv Erritzøe-Jervild principal investigator
Køge Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernia, run by Zealand University Hospital at 2 sites 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 7 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: status not confirmed, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederik helgstrand, MD (freh@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01501682, 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 29 Dec 2011.