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OpenTrials
Completed

NCT Number: NCT04801394

Retrospective Analysis on Large Incisional Hernia in High Risk Patients

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.

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Key information

Conditions

Incisional Hernia Hernia Large Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hernioplastic and insertion of FLaPp® composite mesh

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.

Primary outcomes

  1. Early surgical outcome of FLaPp® prosthesis classified according to Clavien Dindo Classification

    Time frame: 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

  2. Evaluation of pain after FLaPp® prosthesis

    Time frame: one month

    Evaluation of postoperative pain through Visual Analague Scale

  3. Mortality after FLaPp® prosthesis

    Time frame: One month

    Rate of posoperative mortality after FLaPp® prosthesis

Secondary outcomes

  1. incisional hernia recurrence at medium term

    Time frame: 36 months

    assessment of postoperative recurrence after 36 months evaluated with clinical outcpatient control and CT scan

  2. Patients' satisfatcion after FLaPp® prosthesis

    Time frame: 36 months

    Evaluated through the so-called 36 items Short-Form health survey

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2021
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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