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

Not Applicable

Withdrawn

• Conditions: Umbilical Hernia
• Interventions: Device: Marlex; Device: Enform Mesh

• Registration Number: NCT05994248
• Lead Sponsor: Wake Forest University Health Sciences

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 Timeline

• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-08
• Study First Posted: 2023-08-16
• Status Verified: 2024-05
• Study Start: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2029-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 420

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-Absorbable Synthetic Mesh	Marlex	Subjects randomized to the non-absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Marlex mesh.
Absorbable Synthetic Mesh	Enform Mesh	Subjects randomized to the absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Enform mesh.

Primary Outcome Measures

Name	Time	Method
Umbilical Hernia Recurrence	3-years postoperatively	The rate of hernia recurrence 3-years postoperatively

Secondary Outcome Measures

Name	Time	Method
Postoperative Outcomes - Length of stay	3-years postoperatively	The length of stay (LOS) in the hospital postoperatively
Postoperative Outcome - 30-day readmission	30-days postoperatively	The rate of 30-day readmission
Mesh Related Complication - Mesh infection	1-year postoperatively	The rate of mesh infection within 1-year postoperatively
Postoperative Outcome - Seroma	3-years postoperatively	The rate seroma within 3-years postoperatively
Postoperative Outcomes - Mortality	3-years postoperatively	The rate of mortality within 3-years postoperatively
Mesh Related Complication - Mesh excision	1-year postoperatively	The rate of mesh excision within 1-year postoperatively
Postoperative Outcome - Hematoma	3-years postoperatively	The rate of hematoma within 3-years postoperatively
Postoperative Outcomes - Intra-abdominal abscess	3-years postoperatively	The rate of intra-abdominal abscess within 3-years postoperatively
Postoperative Outcome - Wound cellulitis	3-years postoperatively	The rate of wound cellulitis within 3-years postoperatively
Postoperative Outcome - Wound infection	3-years postoperatively	The rate of wound infection within 3-years postoperatively
Quality of Life (QOL)	3-years postoperatively	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.
Postoperative Outcome - Superficial wound breakdown	3-years postoperatively	The rate of superficial wound breakdown within 3-years postoperatively

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States