Heavy Weight Versus Medium Weight Mesh in Ventral Hernia Repair

Ventral Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082391
• Other study ID #: 16-1643
• Status: Completed
• Phase: N/A
• Start date: March 14, 2017
• Est. completion date: May 28, 2020

Study information

• Verified date: June 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 28, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Device:
• Heavy weight Mesh
Patients will undergo ventral hernia repair with heavy weight mesh.
• Medium weight Mesh
Patients will undergo ventral hernia repair with medium weight mesh.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Subjects With Hernia Recurrence	Hernia recurrence will be determined using the Ventral Hernia Recurrence Inventory.	One Year Postoperatively
Secondary	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
Secondary	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