Retrospective Analysis on Large Incisional Hernia in High Risk Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04801394

Enrollment

Registered

2021-03-17

Start date

2010-04-01

Completion date

2016-12-31

Last updated

2022-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia, Large Incisional Hernia

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.

Interventions

PROCEDUREhernioplastic 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026