Incisional HerniaNCT04801394
Retrospective Analysis on Large Incisional Hernia in High Risk Patients
A study testing hernioplastic and insertion of FLaPp® composite mesh in people with Incisional Hernia and Large Incisional Hernia, run by University of Campania Luigi Vanvitelli.
Trial summary
Large incisional hernia (LIH) is a challenging condition where the abdominal wall is hopelessly compromised. Nowadays the best treatment option in this particularly frail subset of patients is a major issue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia, Large Incisional Hernia
- What is being tested?
- hernioplastic and insertion of FLaPp® composite mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2010to 31 Dec 2016
- 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
- symptomatic patients with midline Large incisional hernia
Who cannot join
- lateral incisional hernias
- collagen diseases
- patients who recently have undergone chemotherapy and/or radiation therapy
- patients with acquired immunodeficiency
About this study
Official title: Retrospective Analysis on Large Incisional Hernia in High Risk Patients: the Innovative "Neo-peritoneum" Approach With a Composite Mesh
Large incisional hernia (LIH) is a challenging condition where the abdominal wall is hopelessly compromised. Nowadays the best treatment option in this particularly frail subset of patients is a major issue. The Auhtors proposed the clinical experience with an innovative approach with the composite Free Lateral Polypropylene prosthesis (FLaPp®) mesh fashioned as "neoperitoneum" analyzing its feasibility and short/medium term results.
- Conditions
- Incisional Hernia, Large Incisional Hernia
- Being tested
- hernioplastic and insertion of FLaPp® composite mesh
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hernioplastic and insertion of FLaPp® composite meshProcedure or surgery
After the reduction of the large incisional hernia, the polypropylene transparent film of this mesh (lower flap) was sutured to the margins of the residual peritoneum and posterior rectus sheath as a "neo-peritoneum"; the macroporous light polypropylene layer (upper flap) was then sutured circumferentially with full-thickness transabdominal stitches in the retromuscular space.
| Study group | Role | What they receive |
|---|---|---|
| Mesh Group | Experimental | Patient with large incisional hernia treated with FLaPp® mesh as neoperineium Receives: Procedure: hernioplastic and insertion of FLaPp® composite mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early surgical outcome of FLaPp® prosthesis classified according to Clavien Dindo Classification
evaluation of feasibility of FLaPp® prosthesis in patients affected by LIH by the assessment of postoperative morbidity classified according to Clavien Dindo Classification
Measured: one month
Evaluation of pain after FLaPp® prosthesis
Evaluation of postoperative pain through Visual Analague Scale
Measured: one month
Mortality after FLaPp® prosthesis
Rate of posoperative mortality after FLaPp® prosthesis
Measured: One month
Secondary outcomes (2)
incisional hernia recurrence at medium term
assessment of postoperative recurrence after 36 months evaluated with clinical outcpatient control and CT scan
Measured: 36 months
Patients' satisfatcion after FLaPp® prosthesis
Evaluated through the so-called 36 items Short-Form health survey
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Apr 2010
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Gambardella, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801394
- Sponsor's protocol ID
- Combined mesh
- Status last verified
- Jun 2022
- First submitted
- 11 Mar 2021
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis on Large Incisional Hernia in High Risk Patients: the Innovative "Neo-peritoneum" Approach With a Composite Mesh
- ClinicalTrials.gov ID
- NCT04801394
- Acronym / sponsor ID
- Combined mesh
- Conditions
- Incisional Hernia, Large Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Apr 2010 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 17 Mar 2021 (actual)
- 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.
Large incisional hernia (LIH) is a challenging condition where the abdominal wall is hopelessly compromised. Nowadays the best treatment option in this particularly frail subset of patients is a major issue. The Auhtors proposed the clinical experience with an innovative approach with the composite Free Lateral Polypropylene prosthesis (FLaPp®) mesh fashioned as "neoperitoneum" analyzing its feasibility and short/medium term results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesh Group | Experimental | Procedure: hernioplastic and insertion of FLaPp® composite meshPatient with large incisional hernia treated with FLaPp® mesh as neoperineium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- symptomatic patients with midline Large incisional hernia
Key exclusion criteria (4 listed)
- lateral incisional hernias
- collagen diseases
- patients who recently have undergone chemotherapy and/or radiation therapy
- patients with acquired immunodeficiency
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 |
|---|---|---|
| hernioplastic and insertion of FLaPp® composite meshAfter the reduction of the large incisional hernia, the polypropylene transparent film of this mesh (lower flap) was sutured to the margins of the residual peritoneum and posterior rectus sheath as a "neo-peritoneum"; the macroporous light polypropylene layer (upper flap) was then sutured circumferentially with full-thickness transabdominal stitches in the retromuscular space. | Procedure or surgery | Mesh Group |
Primary outcome
Early surgical outcome of FLaPp® prosthesis classified according to Clavien Dindo Classification
Time frame: one month
evaluation of feasibility of FLaPp® prosthesis in patients affected by LIH by the assessment of postoperative morbidity classified according to Clavien Dindo Classification
Evaluation of pain after FLaPp® prosthesis
Time frame: one month
Evaluation of postoperative pain through Visual Analague Scale
Mortality after FLaPp® prosthesis
Time frame: One month
Rate of posoperative mortality after FLaPp® prosthesis
2 secondary outcomes
incisional hernia recurrence at medium term
Time frame: 36 months
Patients' satisfatcion after FLaPp® prosthesis
Time frame: 36 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 15 Jun 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing hernioplastic and insertion of FLaPp® composite mesh in people with Incisional Hernia and Large Incisional Hernia, run by University of Campania Luigi Vanvitelli.
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 4 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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Early surgical outcome of FLaPp® prosthesis classified according to Clavien Dindo Classification (time frame: one month). The study lists 3 primary outcomes in all. 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 15 Jun 2022.