Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair
Condition: Ventral Hernia
MeSH terms: Hernia; Hernia, Ventral
Study type: Interventional

Summary: 
      The purpose of this study is to determine if mesh weight has an impact on postoperative pain,
      ventral hernia recurrence, incidence of deep wound infection, and overall quality of life
      following ventral hernia repair with mesh.
    

Detailed description: 
      Approximately five million laparotomies are performed annually in the United States with
      upwards of 25% of these patients developing a ventral hernia postoperatively. Despite the
      prevalence of ventral hernias, the surgical approach to these procedures lacks
      standardization. In fact, nearly 20%-50% of patients undergoing ventral hernia repair (VHR)
      will experience a hernia recurrence.

      There are several factors that can contribute to ventral hernia recurrence. One of these is
      the use of prosthetic reinforcement. Although previous studies have shown that the use of
      mesh during VHR significantly decreases the risk of ventral hernia recurrence, guidelines for
      the ideal prosthetic material remain unknown. In terms of synthetic mesh, there are
      proponents that argue the value of medium weight material (40-60 g/m2) in order to combat the
      risk of postoperative deep surgical site infection and minimize the risk of a "stiff abdomen"
      or chronic pain syndromes.3-5 On the other hand, however, proponents of a heavier weight
      material ( > 80 g/m2) argue that its tensile strength leads to a long-term, durable hernia
      repair with decreased risk of hernia recurrence.

      To help determine if mesh weight has an impact on postoperative pain, we propose a registry
      based, randomized clinical trial (RCT) through the Americas Hernia Society Quality
      Collaborative (AHSQC). The AHSQC is a multicenter, nationwide quality improvement effort with
      a mission to improve value in hernia care.6 Data are collected prospectively in the routine
      care of hernia patients for quality improvement purposes. The information collected in the
      AHSQC offers a natural repository of information that can be used for research, in addition
      to its quality improvement purpose. The investigators hypothesize that patients who undergo
      ventral hernia repair with medium weight mesh will have significantly less pain than those
      patients who undergo ventral hernia repair using heavy weight mesh one year after operation.
      Both the intended randomization arms of the study are accepted standard of care practices in
      use by surgeons.

      Specific Aim #1: To determine if the use of a medium weight material leads to a decrease in
      pain intensity at one year following ventral hernia repair.

      Specific Aim #2: To determine if there is a difference in ventral hernia recurrence at one
      year following surgery.

      Specific Aim #3: To determine if there is a difference in the rate of deep surgical site
      infection at 30-days following surgery between the two mesh types.

      Specific Aim #4: To determine if there is a difference in the quality of life between the two
      groups at one year following surgery.
    

Intervention name(s): Heavy weight Mesh; Medium weight Mesh
Intervention type(s): Device; Device
Intervention description(s): Patients will undergo ventral hernia repair with heavy weight mesh.; Patients will undergo ventral hernia repair with medium weight mesh.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ventral Hernia Repair; Heavy weight Mesh; Medium weight Mesh