Absorbable and Synthetic Mesh: A Multicenter, Prospective, Non-Inferior, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 420
- Primary Endpoint
- Umbilical Hernia Recurrence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- Not provided
Arms & Interventions
Non-Absorbable Synthetic Mesh
Subjects randomized to the non-absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Marlex mesh.
Intervention: Marlex (Device)
Absorbable Synthetic Mesh
Subjects randomized to the absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Enform mesh.
Intervention: Enform Mesh (Device)
Outcomes
Primary Outcomes
Umbilical Hernia Recurrence
Time Frame: 3-years postoperatively
The rate of hernia recurrence 3-years postoperatively
Secondary Outcomes
- Postoperative Outcomes - Length of stay(3-years postoperatively)
- Postoperative Outcome - 30-day readmission(30-days postoperatively)
- Mesh Related Complication - Mesh infection(1-year postoperatively)
- Postoperative Outcome - Seroma(3-years postoperatively)
- Postoperative Outcomes - Mortality(3-years postoperatively)
- Mesh Related Complication - Mesh excision(1-year postoperatively)
- Postoperative Outcome - Hematoma(3-years postoperatively)
- Postoperative Outcomes - Intra-abdominal abscess(3-years postoperatively)
- Postoperative Outcome - Wound cellulitis(3-years postoperatively)
- Postoperative Outcome - Wound infection(3-years postoperatively)
- Quality of Life (QOL)(3-years postoperatively)
- Postoperative Outcome - Superficial wound breakdown(3-years postoperatively)