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

NCT05994248 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-06-04

No results posted yet for this study

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.

Conditions

  • Umbilical Hernia

Interventions

DEVICE

Enform Mesh

Use of absorbable mesh in umbilical hernia repair

DEVICE

Marlex

Use of non-absorbable mesh in umbilical hernia repair

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Todd Heniford, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2029-06-30
Completion
2029-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05994248 on ClinicalTrials.gov