Retrospective Analysis on Large Incisional Hernia in High Risk Patients

Incisional Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04801394
• Other study ID #: Combined mesh
• Status: Completed
• Phase: N/A
• Start date: April 1, 2010
• Est. completion date: December 31, 2016

Study information

• Verified date: June 2022
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Large Incisional Hernia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Evaluation of pain after FLaPp® prosthesis	Evaluation of postoperative pain through Visual Analague Scale	one month
Primary	Mortality after FLaPp® prosthesis	Rate of posoperative mortality after FLaPp® prosthesis	One month
Secondary	incisional hernia recurrence at medium term	assessment of postoperative recurrence after 36 months evaluated with clinical outcpatient control and CT scan	36 months
Secondary	Patients' satisfatcion after FLaPp® prosthesis	Evaluated through the so-called 36 items Short-Form health survey	36 months