Comparative Study on Self-adhesive Mesh for Open Inguinal Hernia Repair
Condition: Hernia, Inguinal
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Tension-less mesh repair is the most common procedure for inguinal hernia. Conventional heavy
      weight polypropylene meshes have been reported to stimulate inflammatory reaction and this is
      responsible for mesh shrinkage and postoperative chronic groin pain. Moreover, the fixation
      of the mesh with sutures is a tedious procedure and accounts for the majority of the
      operating time. A self gripping semi-absorbable mesh has been developed for anterior tension
      free inguinal hernia repair. It has the benefit of light weight property and does not require
      sutures for fixation. This study aims to compare the outcome of this self-gripping light
      weight mesh with the conventional heavy weight polypropylene mesh in inguinal hernia repair.
    

Detailed description: 
      Tension free mesh repair is the most common procedure for inguinal hernia repair.
      Conventional heavy weight polypropylene meshes have been reported to stimulate inflammatory
      reaction and this is responsible for mesh shrinkage when scar tissues are formed. In
      addition, the mesh requires fixation with sutures and there has been postulation that the
      fixation technique is related to postoperative chronic groin pain. Therefore, some authors
      have recommended the use of light-weight meshes and to limit the extent of fixation or to use
      non-compressive absorbable devices. In order to reduce the complications, a new self-gripping
      semi-resorbable mesh has been developed for anterior tension-free inguinal hernia repair.

      The aim of this study is to compare the difference in operating time for open inguinal hernia
      repair with conventional prolene mesh and ProgripTM, which is a light-weight mesh with
      self-adhesive mechanism.

      Methodology: Patients present with first episode of inguinal hernia are included into the
      study. Those with a sizable defect (>3cm defect), bilateral, inguino-scrotal hernia,
      irreducible, recurrence are excluded from study. Informed consents are signed before
      procedures and details of randomization are explained. Operations are performed by or under
      the supervision of specialist surgeons. Standardized inguinal dissection are performed.
      Randomization is carried out immediately before placement of mesh and after adequate inguinal
      dissection. PI / co-investigator phone to research assistant and ask for randomization result
      generated by computer. Total operative time, time from mesh placement to wound closure, blood
      loss, intra-operative complications, hospital stay, post-operative pain and analgesic used
      are documented.

      Post-operative follow-up: Follow-up on day 14, 3 months, 6 months and 1 year post-op. Pain
      score, paraesthesia , chronic discomfort / pain, recurrence, seroma formation, testicular
      atrophy are documented. Thereafter, yearly follow-up is performed at clinic or by telephone
      to document the recurrence and chronic pain.

      Parietene ProGrip™ (PP1208DR/ PP1208DL) Manufacturer: Sofradim Production Material:
      Monofilaments of polypropylene and polylactic acid (PLA) Color: Clear (undyed) Weight: 80g/m2
      (before PLA resorbtion), 40g/m2 (after PLA resorbtion) Poresize: 1.7mm x 1mm

      Material detailed description:

      Parietene ProGrip™ is the first bio-component mesh comprised of monofilament polyester and a
      resorbable polylactic acid (PLA) gripping system which perfects true tension-free repair. The
      microhools cover the entire underside of the material allow complete anchoring of the mesh on
      the tissue. Self-gripping features also allows a strong and solid self-anchoring fixation and
      therefore making the hernia sac to fit perfectly to groin anatomy and move less underneath
      the prosthesis. Therefore, less suture is required and so operative time can be saved. Also
      less chance of nerve entrapment may cause low postoperative pain.

      Surgipro Mesh (SPMM-35) Material: Monofilaments of polypropylene Color: Clear (undyed)
      Measurement: 15cmx15cm Thickness: 0.57mm

      Description:

      SURGIPRO Mesh is a non-absorbable, inert, sterile, porous surgical mesh knitted from
      mono-filament fibers of polypropylene polymer. The mesh exhibits high burst strength and
      tensile strength. The mesh is knitted in such fashion as to interconnect each mono-filament
      fiber and provide bi-dimensional elasticity while allowing the mesh to be cut to shape
      without unraveling.

      Actions:

      SURGIPRO Mesh is a porous, non-absorbable mesh used to repair or reinforce fascial defects
      following surgery or trauma and serves to provide additional support to such wounds during
      and following the wound healing period. Animal studies have shown that the polypropylene
      mono-filament fibers from which SURGIPRO Mesh is manufactured elicit a minimal acute
      inflammatory reaction in tissue, which is then followed by gradual encapsulation by fibrous
      tissue. In-growth of this fibrous tissue is permitted by the porosity of the knitted mesh
      structure. The mesh remains soft and pliable and the non-absorbable polypropylene fibers
      comprising the mesh resists loss of tensile strength in vivo.
    

Intervention name(s): PROGRIP; POLYPROPYLENE
Intervention type(s): Device; Device
Intervention description(s): Use of PROGRIP mesh for open inguinal hernia repair; Use of Polypropylene mesh in open inguinal hernia repair
Other intervention name(s): PROGRIP MESH; Polypropylene mesh
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inguinal hernia; mesh; progrip