NCT03082391

Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair

Long-term Results of Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
DEVICE	Heavy weight Mesh	Patients will undergo ventral hernia repair with heavy weight mesh.
DEVICE	Medium weight Mesh	Patients will undergo ventral hernia repair with medium weight mesh.

Timeline

• Start date: 2017-03-14
• Primary completion: 2020-05-28
• Completion: 2020-05-28
• First posted: 2017-03-17
• Last updated: 2022-07-14
• Results posted: 2022-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study