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Retrospective Analysis on Large Incisional Hernia in High Risk Patients

Primary Purpose

Incisional Hernia, Large Incisional Hernia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hernioplastic and insertion of FLaPp® composite mesh
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incisional Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Mesh Group

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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
    Evaluation of pain after FLaPp® prosthesis
    Evaluation of postoperative pain through Visual Analague Scale
    Mortality after FLaPp® prosthesis
    Rate of posoperative mortality after FLaPp® prosthesis

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 11, 2021
    Last Updated
    June 14, 2022
    Sponsor
    University of Campania "Luigi Vanvitelli"
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04801394
    Brief Title
    Retrospective Analysis on Large Incisional Hernia in High Risk Patients
    Official Title
    Retrospective Analysis on Large Incisional Hernia in High Risk Patients: the Innovative "Neo-peritoneum" Approach With a Composite Mesh
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2010 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    December 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Campania "Luigi Vanvitelli"

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Incisional Hernia, Large Incisional Hernia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mesh Group
    Arm Type
    Experimental
    Arm Description
    Patient with large incisional hernia treated with FLaPp® mesh as neoperineium
    Intervention Type
    Procedure
    Intervention Name(s)
    hernioplastic and insertion of FLaPp® composite mesh
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Early surgical outcome of FLaPp® prosthesis classified according to Clavien Dindo Classification
    Description
    evaluation of feasibility of FLaPp® prosthesis in patients affected by LIH by the assessment of postoperative morbidity classified according to Clavien Dindo Classification
    Time Frame
    one month
    Title
    Evaluation of pain after FLaPp® prosthesis
    Description
    Evaluation of postoperative pain through Visual Analague Scale
    Time Frame
    one month
    Title
    Mortality after FLaPp® prosthesis
    Description
    Rate of posoperative mortality after FLaPp® prosthesis
    Time Frame
    One month
    Secondary Outcome Measure Information:
    Title
    incisional hernia recurrence at medium term
    Description
    assessment of postoperative recurrence after 36 months evaluated with clinical outcpatient control and CT scan
    Time Frame
    36 months
    Title
    Patients' satisfatcion after FLaPp® prosthesis
    Description
    Evaluated through the so-called 36 items Short-Form health survey
    Time Frame
    36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Retrospective Analysis on Large Incisional Hernia in High Risk Patients

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