Observational Study to Evaluate Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign)
Condition: Ventral Incisional Hernia
MeSH terms: Hernia; Incisional Hernia
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the efficacy of the Cook Biodesign mesh for the
      repair of complex ventral incisional hernias. Using materials to reinforce tissue defects is
      indicated as standard of care for this type of surgery. The Cook Biodesign mesh is currently
      FDA-approved for implantation to reinforce soft tissues where weakness exists, but the
      investigators would like to collect additional follow-up information to continue to assess
      the durability of the repair after placement of the hernia mesh. This follow-up would include
      the collection of information about complications such as infections and seromas (collections
      of fluid around the surgery site), as well as hernia recurrence and quality of life
      questionnaires. Patients who qualify to take part in this study have been diagnosed with a
      ventral incisional hernia and will have been scheduled for a surgical hernia repair. This
      surgery will be an "open" surgical procedure and reinforcing your tissue with material is
      indicated for this type of hernia repair.
    

Detailed description: 
      Prior to their scheduled surgery, the patient will be consented and will complete a brief
      quality of life survey. They will also be asked some questions about their medical history
      that pertain to the study, such as current/ past abdominal infections and surgeries, history
      of the hernia, comorbidities, etc.

      During the surgery, some key data points will be recorded by the research coordinator, such
      as time of surgery, type of case, size of mesh used, size of the hernia defect, technique
      used, type of sutures used, etc. The mesh will be placed either retrorectus or
      intraperitoneally, after the component separation is complete. The mesh will not be used as a
      "bridge," and the fascial layers will be closed completely.

      The research staff may photograph the repair of an enrolled patient's hernia during their
      treatment and will supply a copy of the photograph to Cook Medical, Inc. if the sponsor's
      review is requested. Any photograph taken for research purposes will be kept in a
      password-protected, encrypted database separate from any patient identifying information.
    

Intervention name(s): Hernia graft/mesh
Intervention type(s): Device
Intervention description(s): observational group
Other intervention name(s): Cook Biodesign hernia graft
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study team will screen the office schedules of the investigators for patients
        presenting for open bowel resection at the Mount Sinai Medical Center. Patients who meet
        the eligibility criteria will be asked if they are interested in volunteering to
        participate in the study.
      
Keywords: hernia repair; ventral incisional hernia; biologic mesh; hernia graft