Incisional Ventral HerniaNCT01953302
Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair
A study testing modified "open mesh technique" in people with Incisional Ventral Hernia and Recurrent Ventral Hernia, run by Varazdin General Hospital at 1 site in Croatia.
Trial summary
Ventral hernias, primary and recurrent, are major surgical challenge. We aim to investigate efficacy of modified technique of ventral hernias repair: an "open intraperitoneal mesh" technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Ventral Hernia, Recurrent Ventral Hernia
- What is being tested?
- modified "open mesh technique"
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteCroatia
- Study dates
- May 2010to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- patients aged 18 years or older
- American Society of Anesthesiologists physical status I, II, III
Who cannot join
- refusal of the patients to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Ventral hernias, primary and recurrent, are major surgical challenge. We aim to investigate efficacy of modified technique of ventral hernias repair: an "open intraperitoneal mesh" technique.
Read the detailed description
We analyzed early postoperative complications (EPCs; wound infection, hematoma, and seroma) and late postoperative complications (recurrence) in 124 patients operated for IHs and recurrent IHs (RIHs) using our new technique. Our technique involved repairing hernias by preserving the hernia sac, which was later used to conceal the mesh that replaced the abdominal wall defect, thus dividing the mesh from subcutaneous tissue.
- Being tested
- modified "open mesh technique"
- Keywords
- ventral hernia, infection, hematoma, seroma, recurrence, mesh technique
- Medical subject headings
- Hernia, Ventral, Infections, Hematoma, Seroma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified "open mesh technique"Procedure or surgery
Also called Proceed Surgical Mesh, VycrilTM,2-0 resorbing sutures
We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.
| Study group | Role | What they receive |
|---|---|---|
| modified "open mesh technique" | Experimental | We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage. Receives: Procedure: modified "open mesh technique" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma)
we counted number of patinetns with wound infection, seroma, hematoma that occured in the early postoperative time
Measured: four weeks after the surgery
Secondary outcomes (1)
Number of Patients With Postoperative Hernia Recurrence
Measured: up to 36 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startMay 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incisional 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Varazdin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ranko Stare, MD, PhD, Principal investigator, Varazdin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953302
- Sponsor's protocol ID
- 24011983
- Status last verified
- Apr 2017
- First submitted
- 21 Sep 2013
- Last updated
- 12 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pajtak A, Stare R, Biskup I, Lukic A, Skorjanec S, Hrzenjak K. A modified open intraperitoneal mesh (Garestin) technique for incisional ventral hernia repair. Asian J Surg. 2017 Jul;40(4):278-284. doi: 10.1016/j.asjsur.2016.02.001. Epub 2016 May 18.
PubMed 27209474
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT01953302
- Acronym / sponsor ID
- 24011983
- Keywords
- ventral hernia, infection, hematoma, seroma, recurrence, mesh technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Varazdin General HospitalUniversity, hospital or other
- Study start
- May 2010 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Posted 12 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ventral hernias, primary and recurrent, are major surgical challenge. We aim to investigate efficacy of modified technique of ventral hernias repair: an "open intraperitoneal mesh" technique.
Detailed description
We analyzed early postoperative complications (EPCs; wound infection, hematoma, and seroma) and late postoperative complications (recurrence) in 124 patients operated for IHs and recurrent IHs (RIHs) using our new technique. Our technique involved repairing hernias by preserving the hernia sac, which was later used to conceal the mesh that replaced the abdominal wall defect, thus dividing the mesh from subcutaneous tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| modified "open mesh technique" | Experimental | Procedure: modified "open mesh technique"We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 18 years or older
- American Society of Anesthesiologists physical status I, II, III
Key exclusion criteria (1 listed)
- refusal of the patients to give informed consent
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 |
|---|---|---|
| modified "open mesh technique"Also: Proceed Surgical Mesh, VycrilTM,2-0 resorbing suturesWe positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh. | Procedure or surgery | modified "open mesh technique" |
Primary outcome
Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma)
Time frame: four weeks after the surgery
we counted number of patinetns with wound infection, seroma, hematoma that occured in the early postoperative time
1 secondary outcome
Number of Patients With Postoperative Hernia Recurrence
Time frame: up to 36 months after the surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27209474Pajtak A, Stare R, Biskup I, Lukic A, Skorjanec S, Hrzenjak K. A modified open intraperitoneal mesh (Garestin) technique for incisional ventral hernia repair. Asian J Surg. 2017 Jul;40(4):278-284. doi: 10.1016/j.asjsur.2016.02.001. Epub 2016 May 18.
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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.
Ranko Stare, MD, PhD principal investigator
Varazdin General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified "open mesh technique" in people with Incisional Ventral Hernia and Recurrent Ventral Hernia, run by Varazdin General Hospital at 1 site in Croatia.
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 Apr 2024. 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 Croatia. 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?
Yes. Results are posted in the registry (first posted 12 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma) (time frame: four weeks after the surgery). 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 NCT01953302, 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 12 Apr 2024.