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

Umbilical Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05994248
• Other study ID #: IRB00097688
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hernia
• Hernia, Umbilical
• Umbilical Hernia

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