Retrospective Analysis on Large Incisional Hernia in High Risk Patients

Study Overview
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Brief Summary
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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.

Official Title
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Retrospective Analysis on Large Incisional Hernia in High Risk Patients: the Innovative Neo-peritoneum Approach With a Composite Mesh

Conditions
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Incisional Hernia, Large Incisional Hernia

Intervention / Treatment
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* Procedure: hernioplastic and insertion of FLaPp® composite mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic patients with midline Large incisional hernia Exclusion Criteria: lateral incisional hernias collagen diseases patients who recently have undergone chemotherapy and/or radiation therapy patients with acquired immunodeficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesh Group<br>Patient with large incisional hernia treated with FLaPp® mesh as neoperineium | Procedure: hernioplastic and insertion of FLaPp® composite mesh<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | one month | 
| Evaluation of pain after FLaPp® prosthesis | Evaluation of postoperative pain through Visual Analague Scale | one month | 
| Mortality after FLaPp® prosthesis | Rate of posoperative mortality after FLaPp® prosthesis | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incisional hernia recurrence at medium term | assessment of postoperative recurrence after 36 months evaluated with clinical outcpatient control and CT scan | 36 months | 
| Patients' satisfatcion after FLaPp® prosthesis | Evaluated through the so-called 36 items Short-Form health survey | 36 months |