Magnetic Resonance Imaging of Mesh Position After Ventral Hernia Repair
Condition: Hernia; Recurrence
MeSH terms: Hernia; Recurrence; Hernia, Ventral
Study type: Observational [Patient Registry]

Summary: 
      Purpose of the study is the visualization of the mesh and the determination of the mesh
      surface observed by MRI at 3 weeks and 13 months after ventral hernia repair with mesh
      visible IPOM (Dynamesh®). We want to prove that with this type of mesh it is possible to
      visualize the mesh position in vivo in a safe manner. This provides long-term benefit to
      early recognize possible recurrence caused by shifting or shrinking of the mesh and to
      provide early treatment.
    

Detailed description: 
      INTRODUCTION:

      The repair of ventral hernias always goes along with a discussion about placing the optimal
      mesh, the optimum mesh position and the optimal fixation method of the mesh against the
      abdominal wall. There are a lot of meshes available of different materials, in different
      sizes and with different properties.

      Penetrating fixation methods of the mesh have a strong positioning as result, but often at
      the cost of increased acute postoperative pain. Less or non-permanent (absorbable) fixation
      may decrease pain but should not risk a less stable mesh fixation ongoing with recurrence due
      to mesh shifting of mesh shrinkage.

      It is indeed known that the majority of implanted meshes do shrink to an extent, which may be
      of disadvantage for the patient. This has already been demonstrated in several animal
      studies, but clinical information on the mesh shrinkage is rare and mostly a result from
      revised surgery.

      All ordinary meshes for repair of abdominal hernia defects, based on polymeric textile, are
      invisible to conventional imaging techniques, inclusive "magnetic resonance imaging" (MRI).
      The IPOM mesh visible (Dynamesh®), developed by a unique method, contains an amount of iron
      particles, woven in the ordinary structure of the mesh, which allows an imaging in the MRI.

      This study aims to visualize the implanted mesh in vivo by MRI. Furthermore, in cooperation
      with Dynamesh, we want to investigate the optimal concentration of iron particle resulting in
      optimal MRI.

      PURPOSE Purpose of the study is the visualization of the mesh and the determination of the
      mesh surface observed by MRI at 3 weeks and 13 months after ventral hernia repair with mesh
      visible IPOM (Dynamesh®). We want to prove that with this type of mesh it is possible to
      visualize the mesh position in vivo in a safe manner. This provides long-term benefit to
      early recognize possible recurrence caused by shifting or shrinking of the mesh and to
      provide early treatment.

      HERNIA REPAIR

        -  Introduction of the visible mesh IPOM (Dynamesh®) via laparoscopy and positioning
           against the abdominal wall with a minimum overlap with the hernia defect of at least 5
           cm in all directions.

        -  The mesh will be fixed with absorbable staples, Secure Traps (Ethicon, Johnson &
           Johnson), in a double crown configuration. The staples are approximately 1.5 to 2 cm at
           distant from each other.

        -  All patients receive a standardized pain treatment protocol. Analgesics used will be
           checked. Visual analog scale (VAS) for pain will be measured at 4 hours, 8 hours, 12
           hours, 16 hours, 20 hours and 24 hours post-operatively and every 12 hours thereafter
           until discharge of the patient.

        -  Pain medication after discharge will be monitored and checked with the patient at each
           consultation.

      Clinical follow-up: clinical follow-up evaluations of patients at 1 and 13 months.

      MRI measurement: post-operative scans and MRI analysis at 1 and 13 months.

      DATA PROTECTION AND PRIVACY OF THE PATIENT All information about this study will be collected
      in EuraHS registry. The data will be entered into the EuraHS platform with a coded number,
      IMAP001, IMAP002, ...

      LONG-TERM OUTCOME The ability to visualize the position of the intra-abdominal surgery mesh
      on the abdominal wall in a secure manner would be a huge step in abdominal wall surgery. It
      would give the surgeon the opportunity to quickly identify a possible loosening or moving or
      shrinking of the prosthesis and thus to prevent recurrence and other long-term complications.
    

Intervention name(s): MRI scan
Intervention type(s): Procedure
Intervention description(s): Visualization of the mesh surface observed with MRI scan at 3 weeks and 13 months after ventral hernia repair with a visible IPOM prosthesis (Dynamesh®)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients scheduled for elective laparoscopic repair of ventral hernia, with inclusion
        of primary and incisional hernias.