Umbilical Hernia
Conditions
Keywords
Randomized Controlled Trial (RCT), Absorbable Mesh, Non-Absorbable Mesh
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEnform Mesh
Use of absorbable mesh in umbilical hernia repair
DEVICEMarlex
Use of non-absorbable mesh in umbilical hernia repair
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older * Primary umbilical hernia repair (UHR) \[as defined by European Hernia Society (EHS) guidelines primary midline abdominal wall defect from 3 cm above to 3 cm below the umbilicus\] * Undergoing elective laparoscopic or open repair * Defect size of 1-4cm2 * Centers for Disease Control and Prevention (CDC) class 1 & 2 wounds
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical Hernia Recurrence | 3-years postoperatively | The rate of hernia recurrence 3-years postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mesh Related Complication - Mesh excision | 1-year postoperatively | The rate of mesh excision within 1-year postoperatively |
| Postoperative Outcome - 30-day readmission | 30-days postoperatively | The rate of 30-day readmission |
| Postoperative Outcome - Seroma | 3-years postoperatively | The rate seroma within 3-years postoperatively |
| Postoperative Outcome - Hematoma | 3-years postoperatively | The rate of hematoma within 3-years postoperatively |
| Postoperative Outcomes - Intra-abdominal abscess | 3-years postoperatively | The rate of intra-abdominal abscess within 3-years postoperatively |
| Mesh Related Complication - Mesh infection | 1-year postoperatively | The rate of mesh infection within 1-year postoperatively |
| Postoperative Outcome - Wound infection | 3-years postoperatively | The rate of wound infection within 3-years postoperatively |
| Postoperative Outcome - Superficial wound breakdown | 3-years postoperatively | The rate of superficial wound breakdown within 3-years postoperatively |
| Postoperative Outcomes - Mortality | 3-years postoperatively | The rate of mortality within 3-years postoperatively |
| Postoperative Outcomes - Length of stay | 3-years postoperatively | The length of stay (LOS) in the hospital postoperatively |
| Quality of Life (QOL) | 3-years postoperatively | QOL within 3-years of surgery as measured by the Carolinas Comfort Scale (CCS), a validated hernia specific QOL questionnaire. The CCS has 23 questions across 3 domains (mesh sensation, pain, and movement) that are scored 0-5 and N/A. Higher scores indicate worse symptoms. A score of 2 or more in any category is considered symptomatic; a score of 0 or 1 is considered asymptomatic. Data will be reported as the frequency and percentage of symptomatic or asymptomatic for each of the 3 domains. |
| Postoperative Outcome - Wound cellulitis | 3-years postoperatively | The rate of wound cellulitis within 3-years postoperatively |
Outcome results
None listed