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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Owen Drive Surgical Clinic of Fayetteville.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Owen Drive Surgical Clinic of Fayetteville
ClinicalTrials.gov Identifier:
NCT01590940
First received: May 2, 2012
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

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

Condition Intervention
Evaluate the Use of a New Mesh Type in Open Inguinal Hernia Repair
Procedure: Open inguinal hernia repair with mesh

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Parietex Plug-and-patch Hernia Mesh in Elective Open Inguinal Hernia Repair: A Pilot Investigation

Resource links provided by NLM:


Further study details as provided by Owen Drive Surgical Clinic of Fayetteville:

Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

n=50 males and females age 18 and up

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590940

Contacts
Contact: Floiras A Morfesis, M.D. (910) 323-0101 morfesis@owendrivesurgical.com
Contact: Brian P Rose, B.S. (910) 987-3670 bpr0807@gmail.com

Locations
United States, North Carolina
Owen Drive Surgical Clinic of Fayetteville Recruiting
Fayetteville, North Carolina, United States, 28304
Contact: F A Morfesis, M.D.    910-323-0101    morfesis@owendrivesurgical.com   
Principal Investigator: F A Morfesis, M.D.         
Sub-Investigator: Brian P Rose, B.S.         
Sponsors and Collaborators
Owen Drive Surgical Clinic of Fayetteville
Covidien
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Owen Drive Surgical Clinic of Fayetteville
ClinicalTrials.gov Identifier: NCT01590940     History of Changes
Other Study ID Numbers: ODSC001
Study First Received: May 2, 2012
Last Updated: May 3, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on August 21, 2014