Umbilical Hernia Clinical Trial
Official title:
Absorbable and Synthetic Mesh: A Multicenter, Prospective, Non-Inferior, Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 420 |
Est. completion date | June 2029 |
Est. primary completion date | June 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Carolinas Medical Center | Charlotte | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Umbilical Hernia Recurrence | The rate of hernia recurrence 3-years postoperatively | 3-years postoperatively | |
Secondary | Mesh Related Complication - Mesh infection | The rate of mesh infection within 1-year postoperatively | 1-year postoperatively | |
Secondary | Mesh Related Complication - Mesh excision | The rate of mesh excision within 1-year postoperatively | 1-year postoperatively | |
Secondary | Postoperative Outcome - 30-day readmission | The rate of 30-day readmission | 30-days postoperatively | |
Secondary | Postoperative Outcome - Seroma | The rate seroma within 3-years postoperatively | 3-years postoperatively | |
Secondary | Postoperative Outcome - Hematoma | The rate of hematoma within 3-years postoperatively | 3-years postoperatively | |
Secondary | Postoperative Outcomes - Intra-abdominal abscess | The rate of intra-abdominal abscess within 3-years postoperatively | 3-years postoperatively | |
Secondary | Postoperative Outcome - Wound cellulitis | The rate of wound cellulitis within 3-years postoperatively | 3-years postoperatively | |
Secondary | Postoperative Outcome - Wound infection | The rate of wound infection within 3-years postoperatively | 3-years postoperatively | |
Secondary | Postoperative Outcome - Superficial wound breakdown | The rate of superficial wound breakdown within 3-years postoperatively | 3-years postoperatively | |
Secondary | Postoperative Outcomes - Mortality | The rate of mortality within 3-years postoperatively | 3-years postoperatively | |
Secondary | Postoperative Outcomes - Length of stay | The length of stay (LOS) in the hospital postoperatively | 3-years postoperatively | |
Secondary | 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 |
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