Retrospective Analysis on Large Incisional Hernia in High Risk Patients

Not Applicable

Completed

• Conditions: Large Incisional Hernia; Incisional Hernia
• Interventions: Procedure: hernioplastic and insertion of FLaPp® composite mesh

• 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

Study Timeline

• Study Start: 2010-04-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-17
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesh Group	hernioplastic and insertion of FLaPp® composite mesh	Patient with large incisional hernia treated with FLaPp® mesh as neoperineium

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