Wake Forest University Health Sciences
The goal of this study is to see which of two types of mesh is better for fixing an umbilical hernia. One type of mesh is an absorbable synthetic mesh, which goes away on its own in the body, and the other type of mesh is a non-absorbable mesh, which stays in the body forever. The researchers will check if the hernia comes back, how it affects the patient's quality of life, and if there are any problems after the surgery during a three-year period.
Umbilical Hernia
Enform Mesh
Marlex
NA
The goal of this study is to compare the use of absorbable synthetic (AS) mesh versus non-absorbable mesh (NAS) mesh to determine the 3-year recurrence, quality of life (QOL) and postoperative complications in umbilical hernia repair. Patients will be randomized into one of two arms to receive an absorbable (Enform) mesh or non-absorbable (Marlex) mesh. Patients will undergo an umbilical hernia repair with the mesh assigned to their randomization cohort. The hernia recurrence, quality of life and postoperative outcomes to determine if the two meshes are non-inferior.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 420 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Absorbable and Synthetic Mesh: A Multicenter, Prospective, Non-Inferior, Randomized Controlled Trial |
| Actual Study Start Date : | 2025-03 |
| Estimated Primary Completion Date : | 2029-06 |
| Estimated Study Completion Date : | 2029-06 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204