Status:

WITHDRAWN

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

Lead Sponsor:

Wake Forest University Health Sciences

Conditions:

Umbilical Hernia

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

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 complic...

Eligibility Criteria

Inclusion

  • 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

  • None

Key Trial Info

Start Date :

March 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2029

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT05994248

Start Date

March 1 2025

End Date

June 1 2029

Last Update

June 4 2025

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