An interventional study of hernioplastic and insertion of FLaPp® composite mesh in Incisional Hernia and Large Incisional Hernia, sponsored by University of Campania Luigi Vanvitelli. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-15.
Sponsored by University of Campania Luigi Vanvitelli · Not applicable, Interventional, and Treatment
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 43 is below the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →University of Campania Luigi Vanvitelli is the lead sponsor of 170 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient with large incisional hernia treated with FLaPp® mesh as neoperineium
Procedure: hernioplastic and insertion of FLaPp® composite mesh
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.
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
Time frame: one month
Evaluation of pain after FLaPp® prosthesis
Evaluation of postoperative pain through Visual Analague Scale
Time frame: one month
Mortality after FLaPp® prosthesis
Rate of posoperative mortality after FLaPp® prosthesis
Time frame: One month
incisional hernia recurrence at medium term
assessment of postoperative recurrence after 36 months evaluated with clinical outcpatient control and CT scan
Time frame: 36 months
Patients' satisfatcion after FLaPp® prosthesis
Evaluated through the so-called 36 items Short-Form health survey
Time frame: 36 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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University of Campania Luigi Vanvitelli