Ventral Hernia
Conditions
Keywords
Ventral Hernia Repair, Heavy weight Mesh, Medium weight Mesh
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.
Interventions
DEVICEHeavy weight Mesh
Patients will undergo ventral hernia repair with heavy weight mesh.
DEVICEMedium weight Mesh
Patients will undergo ventral hernia repair with medium weight mesh.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Hernia Recurrence | One Year Postoperatively | Hernia recurrence will be determined using the Ventral Hernia Recurrence Inventory. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Heavy Weight Mesh Intervention: Patients will undergo ventral hernia repair with implantation of a heavyweight mesh.
Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh. | 173 |
| Medium Weight Mesh Intervention: Patients will undergo ventral hernia repair with implantation of a mediumweight mesh.
Heavyweight Mesh: Patients will undergo ventral hernia repair with heavweight mesh.
Mediumweight Mesh: Patients will undergo ventral hernia repair with mediumweight mesh. | 177 |
| Total | 350 |
Baseline characteristics
| Characteristic | Medium Weight Mesh | Total | Heavy Weight Mesh |
|---|---|---|---|
| Age, Continuous | 59.31 Years STANDARD_DEVIATION 11.36 | 59.23 Years STANDARD_DEVIATION 11.34 | 59.15 Years STANDARD_DEVIATION 11.35 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 177 participants | 350 participants | 173 participants |
| Sex: Female, Male Female | 91 Participants | 175 Participants | 84 Participants |
| Sex: Female, Male Male | 86 Participants | 175 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 173 | 0 / 177 |
| other Total, other adverse events | 46 / 173 | 67 / 177 |
| serious Total, serious adverse events | 12 / 173 | 17 / 177 |
Outcome results
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.
Time frame: One Year Postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Heavy Weight Mesh | Pain Scores | 30.7 T-Score |
| Medium Weight Mesh | Pain Scores | 30.7 T-Score |
Secondary
Deep Wound Infection
The occurrence of a deep wound infection will be determine based on physical examination and/or computed tomography scanning.
Time frame: 30-Days Postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Heavy Weight Mesh | Deep Wound Infection | 3 Participants |
| Medium Weight Mesh | Deep Wound Infection | 5 Participants |
Secondary
Number of Subjects With Hernia Recurrence
Hernia recurrence will be determined using the Ventral Hernia Recurrence Inventory.
Time frame: One Year Postoperatively
Population: All subjects for both arms were assessed for hernia recurrence, numbers reported below are the number who had recurrence through the following methods of assessment. Some subjects will be in multiple categories
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Heavy Weight Mesh | Number of Subjects With Hernia Recurrence | Physical Exam | 2 participants |
| Heavy Weight Mesh | Number of Subjects With Hernia Recurrence | Radiographic- assessed using CT scan | 3 participants |
| Heavy Weight Mesh | Number of Subjects With Hernia Recurrence | Composite Hernia Recurrence (max Sn) includes subjects answering bulge yes and no further follow up | 42 participants |
| Heavy Weight Mesh | Number of Subjects With Hernia Recurrence | Hernia Recurrence Inventory (HRI)- assessed by subject answering Yes to bulge on questionnaire | 52 participants |
| Heavy Weight Mesh | Number of Subjects With Hernia Recurrence | Composite Hernia Recurrence (Consensus)- Saying yes to bulge, or having a hernia on imaging or exam | 14 participants |
| Heavy Weight Mesh | Number of Subjects With Hernia Recurrence | Composite Hernia Recurrence (max Sp) includes subjects with only imaging or clinical exam | 3 participants |
| Medium Weight Mesh | Number of Subjects With Hernia Recurrence | Composite Hernia Recurrence (max Sp) includes subjects with only imaging or clinical exam | 4 participants |
| Medium Weight Mesh | Number of Subjects With Hernia Recurrence | Physical Exam | 4 participants |
| Medium Weight Mesh | Number of Subjects With Hernia Recurrence | Hernia Recurrence Inventory (HRI)- assessed by subject answering Yes to bulge on questionnaire | 62 participants |
| Medium Weight Mesh | Number of Subjects With Hernia Recurrence | Composite Hernia Recurrence (Consensus)- Saying yes to bulge, or having a hernia on imaging or exam | 13 participants |
| Medium Weight Mesh | Number of Subjects With Hernia Recurrence | Radiographic- assessed using CT scan | 3 participants |
| Medium Weight Mesh | Number of Subjects With Hernia Recurrence | Composite Hernia Recurrence (max Sn) includes subjects answering bulge yes and no further follow up | 48 participants |
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.
Time frame: One Year Postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Heavy Weight Mesh | Quality of Life Scores | 90 score on a scale |
| Medium Weight Mesh | Quality of Life Scores | 86.67 score on a scale |