Retrospective Analysis on Large Incisional Hernia in High Risk Patients
- Conditions
- Large Incisional HerniaIncisional Hernia
- Registration Number
- NCT04801394
- Lead Sponsor
- University of Campania "Luigi Vanvitelli"
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- symptomatic patients with midline Large incisional hernia
- lateral incisional hernias
- collagen diseases
- patients who recently have undergone chemotherapy and/or radiation therapy
- patients with acquired immunodeficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Mortality after FLaPp® prosthesis One month Rate of posoperative mortality after FLaPp® prosthesis
Evaluation of pain after FLaPp® prosthesis one month Evaluation of postoperative pain through Visual Analague Scale
Early surgical outcome of FLaPp® prosthesis classified according to Clavien Dindo Classification 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
- Secondary Outcome Measures
Name Time Method Patients' satisfatcion after FLaPp® prosthesis 36 months Evaluated through the so-called 36 items Short-Form health survey
incisional hernia recurrence at medium term 36 months assessment of postoperative recurrence after 36 months evaluated with clinical outcpatient control and CT scan