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.
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.
Study Type
OBSERVATIONAL
Enrollment
28
Permacol, Parietex, Progrip, Strattice Perforated, and Surgimend.
Tampa General Hospital
Tampa, Florida, United States
University of South Florida - South Tampa Campus
Tampa, Florida, United States
University of South Florida Morsani Center for Advanced Health Care
Tampa, Florida, United States
Incidence of ventral hernia recurrence
Time frame: 2 years from study ventral hernia repair
Time to ventral hernia recurrence
Time frame: 2 years from study ventral hernia repair
Incidence of wound complications
Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation
Time frame: 90 days from study ventral hernia repair
Incidence of enterocutaneous fistula formation
Time frame: 2 years from study ventral hernia repair
Mean Carolinas Comfort Scale score
Patient-centered outcome assessing hernia symptoms - minimum score 0 and maximum total score 115
Time frame: 2 years from study ventral hernia repair
Mean Visual Analog Scale score
Patient-centered outcome - pain score measured by a line in millimeters (0 for no pain and 10 for worst pain imaginable)
Time frame: 2 years from study ventral hernia repair
Mean mesh deployment time
Defined as the time mesh preparation starts to time mesh placement ends
Time frame: during surgery
Mean procedure time
Defined as time of incision to time of closure
Time frame: during surgery
Mean total cost of hospitalization for primary admission
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Defined as cost from surgery to hospital discharge
Time frame: From date of surgery to date of hospital discharge (approximately 3 days)
Mean total cost of surgery for primary admission
Defined as cost from preoperative preparation to anesthesia discharge
Time frame: during surgery
Mean total cost of narcotic usage for primary admission
Defined as cost from narcotic use from surgery to hospital discharge
Time frame: From date of surgery to date of hospital discharge (approximately 3 days)
Mean total cost of readmissions
any hospital readmissions related to ventral hernia complications or recurrence
Time frame: 2 years from study ventral hernia repair