Ventral and Ventral Insicional HerniaPhase 3NCT00455299
LVHR Multicenter Study
A Phase 3 study testing Laparoscopic ventral hernia repair in people with Ventral and Ventral Insicional Hernia, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
The study aims to prove differences or equalities in outcome for patients operated with laparoscopic ventral hernia repair with different methods of fixation of mesh and with or without approximation of defect prior to meshfixation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral and Ventral Insicional Hernia
- What is being tested?
- Laparoscopic ventral hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesNorway
- Study dates
- Mar 2007to Dec 2013
- Phase
- Phase 3
- 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
- secondary or primary ventral hernia
Who cannot join
- Loss of domain, Giant hernia with need of abdominal plastic operation, ASA score above 3
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Randomized Controlled National Multicenter Study for Evaluation of Two Different Ways of Fixation of Mesh-implants and Differences With or Without Approximation of Herniadefects at Laparoscopic Operation for Incisional and Ventral Hernia
The study aims to prove differences or equalities in outcome for patients operated with laparoscopic ventral hernia repair with different methods of fixation of mesh and with or without approximation of defect prior to meshfixation.
Read the detailed description
Patients are randomized to 4 groups: non-absorbable suture fixation and hernia approximation, double crown mesh fixation with titanium spiral tacks with hernia approximation and the same fixations without hernia approximation.
Primary endpoint is recurrence. Secondary endpoints are operating time, adhesion score, mode of entering abdominal cavity, time to recovery, pain durance, seroma formation, aesthetic result (protrusion), organ traumatization infection. Endpoints are correlated to hernia size, body mass index, previous recurrence, age, concurrent illness. Patients are followed 3 years after operation with clinical examination.
300 patients are planned included in primary study. A subgroup of organ transplanted patients is evaluated in a separate study with identical criteria for inclusion.
- Conditions
- Ventral and Ventral Insicional Hernia
- Being tested
- Laparoscopic ventral hernia repair
- Keywords
- Laparoscopy, ventral, hernia, repair, surgery
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ventral hernia repairProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| a | Active comparator | a: suture anchoring + tackers and approximation of defect Receives: Procedure: Laparoscopic ventral hernia repair |
| b | Active comparator | b: suture anchoring + tackers without approximation of defect Receives: Procedure: Laparoscopic ventral hernia repair |
| c | Active comparator | c: only tacker fixation and approximation of defect Receives: Procedure: Laparoscopic ventral hernia repair |
| d | Active comparator | d: only tacker fixation without approximation of defect Receives: Procedure: Laparoscopic ventral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating time
Measured: 30-180 min
Adhesion score
Mode of entering abdominal cavity
Pain durance
Measured: 8 weeks
Seroma formation
Aesthetic result (protrusion)
Measured: 3 years
Infection
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventral and Ventral Insicional HerniaStudies of the same condition, open and under way.
- More trials run by Oslo 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tyco Healthcare Group
- Responsible party
- Principal investigator, Jan Lambrecht, Oslo University Hospital
- Investigators
- Jan Lambrecht, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455299
- Sponsor's protocol ID
- S-06466b
- Status last verified
- Oct 2014
- First submitted
- 2 Apr 2007
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lambrecht JR, Vaktskjold A, Trondsen E, Oyen OM, Reiertsen O. Laparoscopic ventral hernia repair: outcomes in primary versus incisional hernias: no effect of defect closure. Hernia. 2015 Jun;19(3):479-86. doi: 10.1007/s10029-015-1345-x. Epub 2015 Feb 7.
PubMed 25663605Lambrecht JR, Skauby M, Trondsen E, Vaktskjold A, Oyen OM. Laparoscopic repair of incisional hernia in solid organ-transplanted patients: the method of choice? Transpl Int. 2014 Jul;27(7):712-20. doi: 10.1111/tri.12327. Epub 2014 May 9.
PubMed 24684675
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled National Multicenter Study for Evaluation of Two Different Ways of Fixation of Mesh-implants and Differences With or Without Approximation of Herniadefects at Laparoscopic Operation for Incisional and Ventral Hernia
- ClinicalTrials.gov ID
- NCT00455299
- Acronym / sponsor ID
- S-06466b
- Conditions
- Ventral and Ventral Insicional Hernia
- Keywords
- Laparoscopy, ventral, hernia, repair, surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Tyco Healthcare Group
- Study start
- Mar 2007
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Apr 2007 (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 study aims to prove differences or equalities in outcome for patients operated with laparoscopic ventral hernia repair with different methods of fixation of mesh and with or without approximation of defect prior to meshfixation.
Detailed description
Patients are randomized to 4 groups: non-absorbable suture fixation and hernia approximation, double crown mesh fixation with titanium spiral tacks with hernia approximation and the same fixations without hernia approximation.
Primary endpoint is recurrence. Secondary endpoints are operating time, adhesion score, mode of entering abdominal cavity, time to recovery, pain durance, seroma formation, aesthetic result (protrusion), organ traumatization infection. Endpoints are correlated to hernia size, body mass index, previous recurrence, age, concurrent illness. Patients are followed 3 years after operation with clinical examination.
300 patients are planned included in primary study. A subgroup of organ transplanted patients is evaluated in a separate study with identical criteria for inclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| a | Active comparator | Procedure: Laparoscopic ventral hernia repaira: suture anchoring + tackers and approximation of defect |
| b | Active comparator | Procedure: Laparoscopic ventral hernia repairb: suture anchoring + tackers without approximation of defect |
| c | Active comparator | Procedure: Laparoscopic ventral hernia repairc: only tacker fixation and approximation of defect |
| d | Active comparator | Procedure: Laparoscopic ventral hernia repaird: only tacker fixation without approximation of defect |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- secondary or primary ventral hernia
Key exclusion criteria (1 listed)
- Loss of domain, Giant hernia with need of abdominal plastic operation, ASA score above 3
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 |
|---|---|---|
| Laparoscopic ventral hernia repair | Procedure or surgery | a, b, c, d |
Primary outcome
Operating time
Time frame: 30-180 min
Adhesion score
Mode of entering abdominal cavity
Pain durance
Time frame: 8 weeks
Seroma formation
Aesthetic result (protrusion)
Time frame: 3 years
Infection
Time frame: 8 weeks
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 16 Oct 2014.
- Derived from this study: PubMed 25663605Lambrecht JR, Vaktskjold A, Trondsen E, Oyen OM, Reiertsen O. Laparoscopic ventral hernia repair: outcomes in primary versus incisional hernias: no effect of defect closure. Hernia. 2015 Jun;19(3):479-86. doi: 10.1007/s10029-015-1345-x. Epub 2015 Feb 7.
- Derived from this study: PubMed 24684675Lambrecht JR, Skauby M, Trondsen E, Vaktskjold A, Oyen OM. Laparoscopic repair of incisional hernia in solid organ-transplanted patients: the method of choice? Transpl Int. 2014 Jul;27(7):712-20. doi: 10.1111/tri.12327. Epub 2014 May 9.
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.
Jan Lambrecht, MD principal investigator
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laparoscopic ventral hernia repair in people with Ventral and Ventral Insicional Hernia, run by Oslo University Hospital at 2 sites in Norway.
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 16 Oct 2014. 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 Norway. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Operating time (time frame: 30-180 min). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00455299, which also lists 2 linked publications.
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 16 Oct 2014.