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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heavy weight Mesh | Active Comparator | Intervention: Patients will undergo ventral hernia repair with implantation of a heavy weight mesh. |
|
| Medium weight Mesh | Active Comparator | Intervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heavy weight Mesh | Device | Patients will undergo ventral hernia repair with heavy weight mesh. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Rosen, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34524395 | Derived | 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. |
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IPD data will not be shared, rather the results of the aggregate groups of patients will be shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | Heavy Weight Mesh | Intervention: Patients will undergo ventral hernia repair with implantation of a heavy weight mesh. Heavy weight Mesh: Patients will undergo ventral hernia repair with heavy weight mesh. |
| FG001 | Medium Weight Mesh | Intervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Medium Weight Mesh |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | T-Score | One Year Postoperatively |
|
1 year following surgery for hernia repair
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heavy Weight Mesh | Intervention: Patients will undergo ventral hernia repair with implantation of a heavy weight mesh. Heavy weight Mesh: Patients will undergo ventral hernia repair with heavy weight mesh. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Rosen | Cleveland Clinic Foundation | 2164453441 | rosenm@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2018 | Sep 14, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 10, 2019 | Sep 16, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Medium weight Mesh | Device | Patients will undergo ventral hernia repair with medium weight mesh. |
|
| 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 |
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.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
|
|
| Secondary | Number of Subjects With Hernia Recurrence | Hernia recurrence will be determined using the Ventral Hernia Recurrence Inventory. | 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 | Posted | Number | participants | One Year Postoperatively |
|
|
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| Secondary | Deep Wound Infection | The occurrence of a deep wound infection will be determine based on physical examination and/or computed tomography scanning. | Posted | Count of Participants | Participants | 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. | Posted | Median | Inter-Quartile Range | score on a scale | One Year Postoperatively |
|
|
|
| 0 |
| 173 |
| 12 |
| 173 |
| 46 |
| 173 |
| EG001 | Medium Weight Mesh | Intervention: Patients will undergo ventral hernia repair with implantation of a medium weight mesh. 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. | 0 | 177 | 17 | 177 | 67 | 177 |
| Pulmonary Embolism | Vascular disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Respiratory Insufficiency | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Excessive Bleeding | Surgical and medical procedures | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
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| Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
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| Colon Cancer | Gastrointestinal disorders | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | Systematic Assessment |
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| Hematoma | Blood and lymphatic system disorders | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Infection- not otherwise specified | Infections and infestations | Systematic Assessment |
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| Pulmonary Embolism | Vascular disorders | Systematic Assessment |
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| Seroma | General disorders | Systematic Assessment |
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| Surgical Site Infection | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Wound Dehiscence | General disorders | Systematic Assessment |
|
| Contact Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Radiographic- assessed using CT scan |
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| Composite Hernia Recurrence (Consensus)- Saying yes to bulge, or having a hernia on imaging or exam |
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| Composite Hernia Recurrence (max Sn) includes subjects answering bulge yes and no further follow up |
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| Composite Hernia Recurrence (max Sp) includes subjects with only imaging or clinical exam |
|