HerniaNCT01997619
Biological Mesh Repair of Complex Hernias in High Risk Patients
An observational study of Hernia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Complex ventral hernia repair is a significant surgical challenge with high frequencies of both wound complications and recurrence. The Ventral Hernia Working Group (VHWG) described in 2010 recommendations regarding grading and technique of repair, which we have followed since November 2011.The purpose of the this… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hernia
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Nov 2013
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 16 consecutive patients with biological mesh repair
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biological Mesh Repair of Complex Ventral Hernias in High Risk Patients
Complex ventral hernia repair is a significant surgical challenge with high frequencies of both wound complications and recurrence. The Ventral Hernia Working Group (VHWG) described in 2010 recommendations regarding grading and technique of repair, which we have followed since November 2011.The purpose of the this study was to evaluate our results after biologic mesh repair of complex hernias.
Read the detailed description
Obervational study
Primare outcome: Surgical site occurence
Secondary outcome: Hernia recurrence
Biolocal mesh: Ventral hernia repair in a population with severe co-morbidity and contaminated hernia.
- Conditions
- Hernia
- Keywords
- biological mesh, contaminated hernia, abdominal wall reconstruction
- Medical subject headings
- Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical site occurence
Wound infections, redness, seromas, dehiesience at the hernia implant site
Measured: 30 days
Secondary outcomes (1)
hernia recurrence
Hernia recurrence at the hernia implant site
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Preisler, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Linda Bardram, MD, Study chair, Rigshospitalet, Copenhagen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997619
- Sponsor's protocol ID
- 30245705
- Status last verified
- Nov 2013
- First submitted
- 24 Nov 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Mesh Repair of Complex Ventral Hernias in High Risk Patients
- ClinicalTrials.gov ID
- NCT01997619
- Acronym / sponsor ID
- 30245705
- Conditions
- Hernia
- Keywords
- biological mesh, contaminated hernia, abdominal wall reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 28 Nov 2013 (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.
Complex ventral hernia repair is a significant surgical challenge with high frequencies of both wound complications and recurrence. The Ventral Hernia Working Group (VHWG) described in 2010 recommendations regarding grading and technique of repair, which we have followed since November 2011.The purpose of the this study was to evaluate our results after biologic mesh repair of complex hernias.
Detailed description
Obervational study
Primare outcome: Surgical site occurence
Secondary outcome: Hernia recurrence
Biolocal mesh: Ventral hernia repair in a population with severe co-morbidity and contaminated hernia.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 16 consecutive patients with biological mesh repair
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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
surgical site occurence
Time frame: 30 days
Wound infections, redness, seromas, dehiesience at the hernia implant site
1 secondary outcome
hernia recurrence
Time frame: 20 months
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 28 Nov 2013.
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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.
Linda Bardram, MD study chair
Rigshospitalet, Copenhagen, University of Copenhagen
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, run by Copenhagen University Hospital, Rigshospitalet 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 0 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 28 Nov 2013. 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?
surgical site occurence (time frame: 30 days). 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 28 Nov 2013.