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

May 3, 2012 updated by: Owen Drive Surgical Clinic of Fayetteville

Use of Parietex Plug-and-patch Hernia Mesh in Elective Open Inguinal Hernia Repair: A Pilot Investigation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a post-market single center pilot study to evaluate the efficacy and safety of the Parietex plug and patch hernia system following open inguinal hernia repair.

The Parietex plug and patch hernia system is composed of:

  • a pre-cut patch made from lightweight monofilament polyester
  • a semiresorbable disk which is a bio-component made of polyester monofilament and poly-L-lactic acid (PLLA).

Patients who meet criteria for the study will be invited to join the study at their consult prior to surgery. F. Andrew Morfesis M.D. FACS will consent the patient, and offer to answer questions and address concerns. Once the patient has provided informed consent, they will be given a hernia surgery specific survey (mesh specific quality of life scale) that will test parameters such as pain, discomfort in movements, and pain frequency. Post operatively, research assistants will review the chart to collect data on secondary objectives from the Operative Note. This data will be entered into a secure excel database.

It will be explained by Dr. Morfesis that these questionnaires must be completed in-person during subsequent follow-up visits. Follow-up visits will be scheduled at 1 month, 3 months, and 1 year, at which time the patient will be examined, and will fill out the hernia surgery specific measure to evaluate pain at follow up. If patients cannot be scheduled for their follow-up visits, pain questionnaires will be given over the phone by a research assistant to reduce data loss.

Subject Selection

This study will include 50 patients following the criteria described below:

Inclusion Criteria

  • All patients regardless of gender > 18 years of age presenting with inguinal hernias.
  • Subjects will be informed of the nature of the study, and have provided signed written consent.

Exclusion Criteria

Excluded groups will include:

  • children under the age of 18
  • subjects that meet criteria for biologic mesh placement
  • emergency procedure
  • recurrent hernias.

Withdrawal Criteria Subjects may withdraw or be withdrawn from the study at any time. The reason for discontinuation will be collected. Additionally, subjects may be withdrawn from the study by the principle investigator for noncompliance with study procedures.

Study Assessments

The study subjects will be evaluated at the following time points:

Screening (pre-operative) Patients will be informed by Dr. Morfesis about the nature of the study and if they are in agreement to participate the signed consent will be obtained.

Prior medical/surgical history will be obtained at time of consultation. Any additional testing or imaging that may be needed will also be obtained before the time of surgery.

Patients will receive a pre-operative hernia pain scale. This scale has been tailored after numerous validated hernia mesh scales assessing types of pain, frequency of pain, and quality of life.

Procedure OR time Intra-operative device related adverse events Technique Method of fixation Length of hospital stay Mesh handling Type of anesthesia

Follow-up will occur at 1 month, 3 months, and 1 year visit Patients will fill out the hernia pain scale. Wound examination Scar thickness and appearance Suture infections Post-operative device related adverse events Recurrence Chronic groin pain Other complications

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Recruiting
        • Owen Drive Surgical Clinic of Fayetteville
        • Contact:
        • Principal Investigator:
          • F A Morfesis, M.D.
        • Sub-Investigator:
          • Brian P Rose, B.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

n=50 males and females age 18 and up

Description

Inclusion Criteria:

  • All patients regardless of gender > 18 years of age presenting with inguinal hernias.
  • Subjects will be informed of the nature of the study, and have provided signed written consent.

Exclusion Criteria:

  • children under the age of 18
  • subjects that meet criteria for biologic mesh placement
  • emergency procedure
  • recurrent hernias.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Parietex mesh
Enrolled patients who met criteria for inclusion would have undergone open inguinal hernia repair using the Parietex plug and patch hernia system
Procedure: Open inguinal hernia repair with mesh

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Owen Drive Surgical Clinic of Fayetteville

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic - MITG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Florias A Morfesis, M.D., Owen Drive Surgical Clinic
  • Study Chair: Brian P Rose, B.S., The Brody School of Medicine at East Carolina University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ODSC001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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