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

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.

Study Overview

• Status: Withdrawn
• Conditions: Umbilical Hernia
• Intervention / Treatment: Device: Marlex; Device: Enform Mesh

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Todd Heniford, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial (RCT); Absorbable Mesh; Non-Absorbable Mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Infant, Newborn, Diseases; Hernia, Abdominal; Hernia, Ventral; Hernia; Hernia, Umbilical
• Other Study ID Numbers: IRB00097688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be made available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes