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

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.

Study Overview

• Status: Completed
• Conditions: Incisional Hernia; Large Incisional Hernia
• Intervention / Treatment: Procedure: hernioplastic and insertion of FLaPp® composite mesh

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mesh Group; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: Combined mesh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No