Clinical Trial: Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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
Sponsor: The Cleveland Clinic

Current Primary Outcome: Pain [ Time Frame: One Year Postoperatively ]

Pain will be measured using the NIH Promis 3A Pain Scale.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hernia Recurrence [ Time Frame: One Year Postoperatively ]
    Hernia recurrence will be determined using the Ventral Hernia Recurrence Inventory.
  • Deep Wound Infection [ Time Frame: 30-Days Postoperatively ]
    The occurrence of a deep wound infection will be determine based on physical examination and/or computed tomography scanning.
  • Quality of Life [ Time Frame: One Year Postoperatively ]
    Quality of life will be measured using the HerQLes quality of life questionnaire.


Original Secondary Outcome: Same as current

Information By: The Cleveland Clinic

Dates:
Date Received: March 12, 2017
Date Started: February 20, 2017
Date Completion: February 20, 2020
Last Updated: March 20, 2017
Last Verified: March 2017