Use of Parietex Plug and Patch Hernia System in Open Inguinal Hernia Repair
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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 |
| 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 |
n=50 males and females age 18 and up
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| Contact: Floiras A Morfesis, M.D. | (910) 323-0101 | morfesis@owendrivesurgical.com |
| Contact: Brian P Rose, B.S. | (910) 987-3670 | bpr0807@gmail.com |
| 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. | |
| 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 May 16, 2013