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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05994248
Other study ID # IRB00097688
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date June 2029

Study information

Verified date May 2024
Source Wake Forest University Health Sciences
Contact Todd Heniford, MD
Phone 704-355-3168
Email Todd.Heniford@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Enform Mesh
Use of absorbable mesh in umbilical hernia repair
Marlex
Use of non-absorbable mesh in umbilical hernia repair

Locations

Country Name City State
United States Carolinas Medical Center Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

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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