Randomized Controlled Trial (RCT) Umbilical Hernia Repair (UHR) Absorbable vs Non-absorbable Synthetic Mesh

Study Overview
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Brief Summary
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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
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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.

Official Title
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Absorbable and Synthetic Mesh: A Multicenter, Prospective, Non-Inferior, Randomized Controlled Trial

Conditions
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Umbilical Hernia

Intervention / Treatment
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* Device: Enform Mesh
* Device: Marlex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-Absorbable Synthetic Mesh<br>Subjects randomized to the non-absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Marlex mesh. | Device: Marlex<br>* Use of non-absorbable mesh in umbilical hernia repair<br>|
| Active Comparator: Absorbable Synthetic Mesh<br>Subjects randomized to the absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Enform mesh. | Device: Enform Mesh<br>* Use of absorbable mesh in umbilical hernia repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Umbilical Hernia Recurrence | The rate of hernia recurrence 3-years postoperatively | 3-years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesh Related Complication - Mesh infection | The rate of mesh infection within 1-year postoperatively | 1-year postoperatively | 
| Mesh Related Complication - Mesh excision | The rate of mesh excision within 1-year postoperatively | 1-year postoperatively | 
| Postoperative Outcome - 30-day readmission | The rate of 30-day readmission | 30-days postoperatively | 
| Postoperative Outcome - Seroma | The rate seroma within 3-years postoperatively | 3-years postoperatively | 
| Postoperative Outcome - Hematoma | The rate of hematoma within 3-years postoperatively | 3-years postoperatively | 
| Postoperative Outcomes - Intra-abdominal abscess | The rate of intra-abdominal abscess within 3-years postoperatively | 3-years postoperatively | 
| Postoperative Outcome - Wound cellulitis | The rate of wound cellulitis within 3-years postoperatively | 3-years postoperatively | 
| Postoperative Outcome - Wound infection | The rate of wound infection within 3-years postoperatively | 3-years postoperatively | 
| Postoperative Outcome - Superficial wound breakdown | The rate of superficial wound breakdown within 3-years postoperatively | 3-years postoperatively | 
| Postoperative Outcomes - Mortality | The rate of mortality within 3-years postoperatively | 3-years postoperatively | 
| Postoperative Outcomes - Length of stay | The length of stay (LOS) in the hospital postoperatively | 3-years postoperatively | 
| Quality of Life (QOL) | 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. | 3-years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial (RCT), Absorbable Mesh, Non-Absorbable Mesh