Ventral Incisional Hernia
Conditions
Keywords
biologic, prosthetic, mesh
Brief summary
The purpose of this study is to assess the incidence of hernia recurrence with the use of biologic and prosthetic mesh in ventral hernia repair.
Detailed description
Incisional hernias are very common, leading to over 380,000 operative repairs done annually. Despite the commonality of this problem, there has been no single operative repair that has become the standard. This is due to the high recurrence rates with all types of repairs, especially primary suture repair. Because of this, most repairs are done with some type of mesh, either made out of a prosthetic material or biologic material. Mesh repairs, however, have their own problems, namely surgical site infections and potential bowel erosion. Potential complications associated with prosthetic mesh for hernia repairs include: adverse reactions to the mesh, mesh erosion, stricture formation, adhesions resulting in bowel obstruction, enterocutaneous fistulas, injuries to nearby organs, nerves or blood vessels, infection, chronic pain and hernia recurrence. Potential complications associated with biological mesh include: adverse inflammatory response, laxity, eventration, and recurrent herniation. To address these mesh related complications, the separation of components technique was developed to reduce tension on the midline repair and the underlay technique was developed to place the mesh in the retrorectus space. Nevertheless, this technique still has a significant recurrence rate. Therefore, the purpose of this study is to evaluate the effectiveness of biological or prosthetic mesh in incisional hernia repair, by assessing the associated rates of hernia recurrence and complications.
Interventions
DEVICEMesh for hernia repair
Permacol, Parietex, Progrip, Strattice Perforated, and Surgimend.
Sponsors
Integra LifeSciences Corporation
University of South Florida
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients \> 21 years old. * Able to provide informed consent in English or Spanish. * Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion criteria
* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable. * Allergy or hypersensitivity to materials in porcine-based study products, prosthetic or biological meshes, or personal preference. * Male and female patients ≤ 21 years old * History of drug addiction (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or the subject's ability to complete the required follow up. * Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of ventral hernia recurrence | 2 years from study ventral hernia repair |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of wound complications | 90 days from study ventral hernia repair | Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation |
| Incidence of enterocutaneous fistula formation | 2 years from study ventral hernia repair | — |
| Mean Carolinas Comfort Scale score | 2 years from study ventral hernia repair | Patient-centered outcome assessing hernia symptoms - minimum score 0 and maximum total score 115 |
| Mean Visual Analog Scale score | 2 years from study ventral hernia repair | Patient-centered outcome - pain score measured by a line in millimeters (0 for no pain and 10 for worst pain imaginable) |
| Mean mesh deployment time | during surgery | Defined as the time mesh preparation starts to time mesh placement ends |
| Time to ventral hernia recurrence | 2 years from study ventral hernia repair | — |
| Mean total cost of hospitalization for primary admission | From date of surgery to date of hospital discharge (approximately 3 days) | Defined as cost from surgery to hospital discharge |
| Mean total cost of surgery for primary admission | during surgery | Defined as cost from preoperative preparation to anesthesia discharge |
| Mean total cost of narcotic usage for primary admission | From date of surgery to date of hospital discharge (approximately 3 days) | Defined as cost from narcotic use from surgery to hospital discharge |
| Mean total cost of readmissions | 2 years from study ventral hernia repair | any hospital readmissions related to ventral hernia complications or recurrence |
| Mean procedure time | during surgery | Defined as time of incision to time of closure |
Countries
United States
Outcome results
None listed