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Use of Parietex Plug and Patch Hernia System in Open Inguinal Hernia Repair

NCT01590940 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2012-05-04

No results posted yet for this study

Summary

The use of synthetic mesh plugs for open inguinal hernia repair has seen dramatic variability in the number and composition of meshes currently on the world market. The use of biomaterials (PLLA, PGA) in hernia mesh is a relatively new and innovative method. These selected polymers have the ability to degrade while implanted, allowing for sufficient natural tissue healing and scarring. This usage presumably favors a decrease in foreignness, inflammatory reaction, recurrence, and incidence of chronic groin pain. Prior studies with similar plug meshes in the same indication have yielded favorable results which require this mesh to be investigated in its specific application.

Primary Objective

Evaluate the incidence of peri-operative and post-operative complications after the application of the Parietex plug and patch hernia system in open inguinal hernia repair. We will assess the efficacy of this mesh by examination and the application of a pain scale at the following intervals: 1 month, 3 months, and 1 year, respectively. Assessment is intended to evaluate:

* Patient report of pain via their Pain score
* Wound complication
* Incidence of chronic groin pain
* Recurrence rate
* Other complications Secondary Objectives

Record the description and assessment of the Parietex plug and patch hernia system:

* surgical technique
* description of dissection and mesh placement
* method of fixation
* operative times, anesthesia choice
* length of hospital stay
* mesh handling characteristics
* return to daily activities
* overall patient satisfaction

Conditions

  • Evaluate the Use of a New Mesh Type in Open Inguinal Hernia Repair

Interventions

PROCEDURE

Open inguinal hernia repair with mesh

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Owen Drive Surgical Clinic of Fayetteville

    lead OTHER

Principal Investigators

  • Florias A Morfesis, M.D. · Owen Drive Surgical Clinic

  • Brian P Rose, B.S. · The Brody School of Medicine at East Carolina University

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-04-30

Countries

  • United States

Study Locations

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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 NCT01590940 on ClinicalTrials.gov