Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair

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

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.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Device: Heavy weight Mesh; Device: Medium weight 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.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Heavy weight Mesh; Intervention: Patients will undergo ventral hernia repair with implantation of a heavy weight mesh.	Device: Heavy weight Mesh; Patients will undergo ventral hernia repair with heavy weight mesh.
Active Comparator: Medium weight Mesh; Intervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	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.	One Year Postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Hernia Recurrence	Hernia recurrence will be determined using the Ventral Hernia Recurrence Inventory.	One Year Postoperatively
Deep Wound Infection	The occurrence of a deep wound infection will be determine based on physical examination and/or computed tomography scanning.	30-Days Postoperatively
Quality of Life Scores	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.	One Year Postoperatively

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Michael J Rosen, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• Krpata DM, Petro CC, Prabhu AS, Tastaldi L, Zolin S, Fafaj A, Rosenblatt S, Poulose BK, Pierce RA, Warren JA, Carbonell AM, Goldblatt MI, Stewart TG, Olson MA, Rosen MJ. Effect of Hernia Mesh Weights on Postoperative Patient-Related and Clinical Outcomes After Open Ventral Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2021 Dec 1;156(12):1085-1092. doi: 10.1001/jamasurg.2021.4309.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2017
• Primary Completion (Actual): May 28, 2020
• Study Completion (Actual): May 28, 2020

Study Registration Dates

• First Submitted: March 12, 2017
• First Submitted That Met QC Criteria: March 12, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Ventral Hernia Repair; Heavy weight Mesh; Medium weight Mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: 16-1643

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD data will not be shared, rather the results of the aggregate groups of patients will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No