Randomized Controlled Trial (RCT) Umbilical Hernia Repair (UHR) Absorbable vs Non-absorbable Synthetic Mesh
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Non-Absorbable Synthetic Mesh Subjects randomized to the non-absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Marlex mesh. |
Device: Marlex
Use of non-absorbable mesh in umbilical hernia repair
|
| Active Comparator: Absorbable Synthetic Mesh Subjects randomized to the absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Enform mesh. |
Device: Enform Mesh
Use of absorbable mesh in umbilical hernia repair
|
Outcome Measures
Primary Outcome Measures
- Umbilical Hernia Recurrence [3-years postoperatively]
The rate of hernia recurrence 3-years postoperatively
Secondary Outcome Measures
- Mesh Related Complication - Mesh infection [1-year postoperatively]
The rate of mesh infection within 1-year postoperatively
- 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
- Postoperative Outcome - Wound cellulitis [3-years postoperatively]
The rate of wound cellulitis within 3-years 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.
Eligibility Criteria
Criteria
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
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Defect size of 1-4cm2
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Centers for Disease Control and Prevention (CDC) class 1 & 2 wounds
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Carolinas Medical Center | Charlotte | North Carolina | United States | 28204 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Todd Heniford, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00097688