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Procedure

Absorbable vs Non-absorbable Mesh for Umbilical Hernia Repair

N/A

Waitlist Available

Led By Todd Heniford, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-years postoperatively

Awards & highlights

Study Summary

This trial will compare two types of mesh to fix an umbilical hernia, and check for recurrence, QoL, & problems after surgery over 3 yrs.

Who is the study for?

This trial is for adults over 18 with a primary umbilical hernia, which is a gap in the abdominal wall near the belly button. The hernia should be sized between 1-4cm2 and suitable for elective laparoscopic or open repair. Only those with CDC class 1 & 2 wounds, indicating lower infection risk, can join.Check my eligibility

What is being tested?

The study compares two types of surgical mesh used in umbilical hernia repairs: Enform Mesh (absorbable synthetic) that dissolves over time and Marlex (non-absorbable synthetic) that remains permanently. It aims to determine their effectiveness and impact on quality of life over three years.See study design

What are the potential side effects?

Potential side effects may include discomfort at the surgery site, inflammation or infection, allergic reactions to materials used in meshes, chronic pain issues related to mesh presence or absorption process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-years postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-years postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-years postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Umbilical Hernia Recurrence

Secondary outcome measures

Mesh Related Complication - Mesh excision

Mesh Related Complication - Mesh infection

Postoperative Outcome - 30-day readmission

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Non-Absorbable Synthetic MeshExperimental Treatment1 Intervention

Subjects randomized to the non-absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Marlex mesh.

Group II: Absorbable Synthetic MeshActive Control1 Intervention

Subjects randomized to the absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Enform mesh.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,239 Previous Clinical Trials

1,003,763 Total Patients Enrolled

Todd Heniford, MDPrincipal InvestigatorWake Forest University Health Sciences

5 Previous Clinical Trials

688 Total Patients Enrolled

Media Library

Umbilical Hernia Repair (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05994248 — N/A

Umbilical Hernia Research Study Groups: Absorbable Synthetic Mesh, Non-Absorbable Synthetic Mesh

Umbilical Hernia Clinical Trial 2023: Umbilical Hernia Repair Highlights & Side Effects. Trial Name: NCT05994248 — N/A

Umbilical Hernia Repair (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05994248 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new volunteers being accepted for this research endeavor?

"Clinicaltrials.gov data indicates that this trial, which was first posted on November 1st 2023 and last updated eight months ago, is not presently seeking participants. However, there are 150 alternative trials available for those interested in clinical research studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Randomized Controlled Trial (RCT) Umbilical Hernia Repair (UHR) Absorbable vs Non-absorbable Synthetic Mesh". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05994248.

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