Efficacy of Macroporous Polytetrafluoroethylene Mesh in Laparoscopic Hernia Repair
Condition: Hernia, Inguinal
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Inguinal hernia repair is one of the most commonly performed surgeries around the world. It
      accounts for approximately 75% of all abdominal wall hernias and presents a lifetime risk of
      27% in males and 3% in females. Since the modern concept of surgical hernia repair described
      by Bassini in 1887, with the technique that bears his name, several techniques have been
      developed in the last century in order to improve surgical outcomes after inguinal hernia
      repair.

      Different open repairs, such as anterior (Shouldice, McVay) or posterior (Stoppa) approach
      were described and developed, until Lichtenstein described the tension-free hernioplasty
      concept supported by the use of a prosthetic mesh to repair the hernia defect. Notable
      Improvements were observed with this technique in terms of recurrence, pain, and discomfort
      in comparison with previous tension repairs. Considerable advantages over open repair have
      been obtained with the introduction of minimally invasive surgery to inguinal hernia repair,
      in terms of patient comfort and recurrence rates.

      Regarding prosthetic material, meshes have evolved since the first Dacron mesh used by
      Lichtenstein. First generation meshes were manufactured using more material and for this
      reason they have been described as heavyweight meshes. New generation meshes have been
      designed with less material in order to diminish the inflammatory response and foreign body
      reaction, providing less chronic pain with similar recurrence rates than heavyweight meshes.
      The density (or weight) of the mesh, measured in g/m2, is inversely proportional to the size
      of the pore and lately it has been reported that one of the main aspects related to
      prosthetic materials is pore size. Large pore meshes use less material, consequently they
      have been associated with a better tissue ingrowth. The large pore of lightweight meshes is
      conditioned by the less amount of material used.

      All previous studies compare both light and heavyweight polypropylene meshes But in order to
      get a proper comparison of the behavior of meshes in the inguinal region it is important to
      include the material and the pore size. The aim of our study is to compare patient-reported
      outcomes with the use of either a Polytetrafluoroethylene (PTFE) large pore mesh (LP-PTFE) vs
      a small pore polypropylene mesh (SP-PPL).
    

Detailed description: 
      Patients fitted for laparoscopic bilateral inguinal hernia repair will be randomized to
      recieve one of both meshes on study in both inguinal sides.
    

Intervention name(s): Totally Extraperitoneal laparoscopic inguinal hernia repair
Intervention type(s): Procedure
Intervention description(s): Laparoscopic hernioplasty
Other intervention name(s): TEP
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment