Retrospective Analysis on Large Incisional Hernia in High Risk Patients

NCT ID: NCT04801394

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-01
• Study Completion Date: 2016-12-31

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.

Conditions

Incisional Hernia; Large Incisional Hernia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mesh Group

Patient with large incisional hernia treated with FLaPp® mesh as neoperineium

Group Type: EXPERIMENTAL

hernioplastic and insertion of FLaPp® composite mesh

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: lead

Responsible Party

Claudio Gambardella

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Combined mesh

Identifier Type: -

Identifier Source: org_study_id