Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair

Not Applicable

Completed

Conditions: Ventral Hernia

Interventions: Device: Heavy weight Mesh
Device: Medium weight Mesh

Registration Number: NCT03082391

Lead Sponsor: The Cleveland Clinic

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 350

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medium weight Mesh	Heavy weight Mesh	Intervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh.
Heavy weight Mesh	Heavy weight Mesh	Intervention: Patients will undergo ventral hernia repair with implantation of a heavy weight mesh.
Medium weight Mesh	Medium weight Mesh	Intervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh.

Primary Outcome Measures

Name	Time	Method
Pain Scores	One Year Postoperatively	Pain Scores will be measured using the NIH Promis 3A Pain Scale. PROMIS® Pain Intensity 3A is a three-question instrument developed to measure the range of pain experienced in the week prior to assessment. The raw score (3-15) is converted into a T-score where 50 (SD 10) represents the average of people with at least mild pain, higher numbers (maximum 71.8) represent higher than average pain, and the lowest score (30.7) represents no pain.

Secondary Outcome Measures

Name	Time	Method
Deep Wound Infection	30-Days Postoperatively	The occurrence of a deep wound infection will be determine based on physical examination and/or computed tomography scanning.
Number of Subjects With Hernia Recurrence	One Year Postoperatively	Hernia recurrence will be determined using the Ventral Hernia Recurrence Inventory.
Quality of Life Scores	One Year Postoperatively	Quality of life will be measured using the HerQLes quality of life questionnaire. HerQLes is a twelve-question instrument developed to evaluate quality of life and function as it pertains to the abdominal wall. It is converted into a 0-100 scale with 0 representing poor abdominal wall function, and 100 excellent function.