Clinical trial NCT03082391: Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair
Official title: Long-term Results of Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Keywords: Ventral Hernia Repair
Heavy weight Mesh
Medium weight Mesh
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Scores
timeFrame: One Year Postoperatively
Secondary outcomes:
measure: Number of Subjects With Hernia Recurrence
timeFrame: One Year Postoperatively
measure: Deep Wound Infection
timeFrame: 30-Days Postoperatively
measure: Quality of Life Scores
timeFrame: One Year Postoperatively
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Michael J Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.