Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair

NeuroTherapia, Inc.

Status: Completed

Conditions: Ventral Hernia

Treatments: Device: Heavy weight Mesh; Device: Medium weight Mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT03082391

16-1643

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Will undergo a single-stage, open, retromuscular ventral hernia repair
• CDC Wound Class 1
• Able to achieve midline fascial closure
• Hernia defect width less than or equal to 20 centimeters (measured intraoperatively)
• Able to tolerate general anesthesia
• Able to give informed consent

Exclusion criteria

• Patients who are less than 18 years of age
• Patients who undergo emergent ventral hernia repair
• Patients who undergo laparoscopic or robotic ventral hernia repair
• Patients with CDC Wound Class 2, 3, or 4
• Patients who are unable to undergo successful retromuscular mesh placement or who cannot achieve midline fascial closure
• Patients who undergo staged repair of their ventral hernia
• Patients who are unable to give informed consent
• Patients who cannot tolerate general anesthesia
• Patients who are pregnant at the time of surgical intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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350 participants in 2 patient groups

Heavy weight Mesh

Active Comparator group

Description:

Intervention: Patients will undergo ventral hernia repair with implantation of a heavy weight mesh.

Treatment:

Device: Heavy weight Mesh

Medium weight Mesh

Active Comparator group

Description:

Intervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh.

Treatment:

Device: Heavy weight Mesh

Device: Medium weight Mesh