Primary and Secondary Ventral HerniaTIGRNCT01622725
Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.
A study testing Placing the resorbable mesh and Non-resorbable synthetic mesh. in people with Primary and Secondary Ventral Hernia, run by University Hospital, Ghent at 6 sites in 5 countries.
Trial summary
Since abdominal wall hernia repair is currently performed with the use of a mesh, side effects associated with the mesh are frequently reported during long term follow-up. These side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and inflammation of the skin and bowl. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary and Secondary Ventral Hernia
- What is being tested?
- Placing the resorbable mesh and Non-resorbable synthetic mesh.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Feb 2013to 31 Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- Primary and secondary ventral hernia
- less than 20 cm in length
- less than 6 cm in width
Who cannot join
None listed.
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Belgium2 sites
Ghent University Hospital
Ghent, 9000
University Hospital Leuven
Leuven, 3000
About this study
Official title: Recurrence Rate After Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.
Since abdominal wall hernia repair is currently performed with the use of a mesh, side effects associated with the mesh are frequently reported during long term follow-up. These side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing mesh has been developed, which provides sufficient support and strength to allow efficient recovery of the abdominal wall, but also disappear from your body in three years time, so that you no longer have any synthetic material in your body. Previous resorbing meshes also disappeared but over a much shorter period of time, so that the hernia was insufficiently healed, with recurrence as a result.
The TIGR™ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh, made of two commonly used polymers, however it will retain 50% of its initial strength after six months. This in theory is enough to provide support of the collagen healing process during the initial wound-healing phase, but also to support the transition of initial collagen to functional collagen.
Read more
The aim of this study is to compare TIGR™ with large pore mesh used in the repair of the anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias are not part of the study).
Therefore the patients will be divided into two groups, one group will be treated with a resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will be no difference in the medication or the surgical techniques used.
- Conditions
- Primary and Secondary Ventral Hernia
- Being tested
- Placing the resorbable mesh, Non-resorbable synthetic mesh.
- Keywords
- 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.
Placing the resorbable meshProcedure or surgery
Surgery for primary and secondary ventral hernia repair with placing of resorbable mesh.
Non-resorbable synthetic mesh.Procedure or surgery
Surgery for primary and secondary ventral hernia repair with placing of non-resorbable synthetic mesh.
| Study group | Role | What they receive |
|---|---|---|
| Resorbable mesh | Experimental | Long-term resorbable mesh implanted to treat primary and secondary ventral hernia. Receives: Procedure: Placing the resorbable mesh |
| Non-resorbable mesh | Active comparator | Non-resorbable synthetic mesh implanted to treat primary and secondary ventral hernia. Receives: Procedure: Non-resorbable synthetic mesh. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate at 3 years post-surgery.
Clinical evaluation and ultrasound evaluation after 3 years post-surgery.
Measured: 3 years post-surgery
Secondary outcomes (4)
Wound Morbidity 4 weeks post-surgery.
Measured: 4 weeks post-surgery
Pain and discomfort after 1 year post-surgery.
Measured: After 1 year post-surgery
Pain and discomfort after 3 years post-surgery.
Measured: After 3 years post-surgery
Recurrence rate by clinical examination 1 year post-surgery.
Clinical Examination to determine the recurrence rate.
Measured: After 1 year post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startFeb 2013
- Primary completion1 Aug 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary and Secondary Ventral 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Novus Scientific
- Responsible party
- Sponsor
- Investigators
- Frederik Berrevoet, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622725
- Sponsor's protocol ID
- 2012/223
- Acronym
- TIGR
- Status last verified
- May 2024
- First submitted
- 15 Jun 2012
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence Rate After Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.
- ClinicalTrials.gov ID
- NCT01622725
- Acronym / sponsor ID
- TIGR / 2012/223
- Conditions
- Primary and Secondary Ventral Hernia
- Keywords
- ventral hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Novus Scientific
- Study start
- Feb 2013 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Jun 2012 (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.
Since abdominal wall hernia repair is currently performed with the use of a mesh, side effects associated with the mesh are frequently reported during long term follow-up. These side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing mesh has been developed, which provides sufficient support and strength to allow efficient recovery of the abdominal wall, but also disappear from your body in three years time, so that you no longer have any synthetic material in your body. Previous resorbing meshes also disappeared but over a much shorter period of time, so that the hernia was insufficiently healed, with recurrence as a result.
The TIGR™ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh, made of two commonly used polymers, however it will retain 50% of its initial strength after six months. This in theory is enough to provide support of the collagen healing process during the initial wound-healing phase, but also to support the transition of initial collagen to functional collagen.
The aim of this study is to compare TIGR™ with large pore mesh used in the repair of the anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias are not part of the study).
Therefore the patients will be divided into two groups, one group will be treated with a resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will be no difference in the medication or the surgical techniques used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resorbable mesh | Experimental | Procedure: Placing the resorbable meshLong-term resorbable mesh implanted to treat primary and secondary ventral hernia. |
| Non-resorbable mesh | Active comparator | Procedure: Non-resorbable synthetic mesh.Non-resorbable synthetic mesh implanted to treat primary and secondary ventral hernia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary and secondary ventral hernia
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Placing the resorbable meshSurgery for primary and secondary ventral hernia repair with placing of resorbable mesh. | Procedure or surgery | Resorbable mesh |
| Non-resorbable synthetic mesh.Surgery for primary and secondary ventral hernia repair with placing of non-resorbable synthetic mesh. | Procedure or surgery | Non-resorbable mesh |
Primary outcome
Recurrence rate at 3 years post-surgery.
Time frame: 3 years post-surgery
Clinical evaluation and ultrasound evaluation after 3 years post-surgery.
4 secondary outcomes
Wound Morbidity 4 weeks post-surgery.
Time frame: 4 weeks post-surgery
Pain and discomfort after 1 year post-surgery.
Time frame: After 1 year post-surgery
Pain and discomfort after 3 years post-surgery.
Time frame: After 3 years post-surgery
Recurrence rate by clinical examination 1 year post-surgery.
Time frame: After 1 year post-surgery.
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 3 Jun 2024.
- Related InfoLink provided by the sponsor.
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 Berrevoet, MD, PhD principal investigator
University Hospital, Ghent
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placing the resorbable mesh and Non-resorbable synthetic mesh. in people with Primary and Secondary Ventral Hernia, run by University Hospital, Ghent at 6 sites in 5 countries.
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 3 inclusion and 0 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 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Denmark, Poland, Spain, United Kingdom. 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 rate at 3 years post-surgery. (time frame: 3 years post-surgery). 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 3 Jun 2024.