Biomechanically Compatible,Minimally Invasive Technique for Recurrence Free Groin Hernia Repair

Study Overview
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Brief Summary
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A bio-mechanically compatible, minimally invasive technique for recurrence-free groin hernia repair by implantation of Tensiflex mesh prosthesis for the enhancement of the tissue tensile strength of the fascia transversalis.

Detailed Description
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Hernia recurrences post-repair remain a confounding problem. The prospective study described herein tested Cooper's paradigm, which holds that abdominal pressure exceeding abdominal wall resistance causes hernia, by incorporating the Tensiflex mesh prosthesis which is a modified version of mesh prosthesis of Stoppa technique in the surgical treatment of patients with hernia. The study was 2-phased: the first phase involved the pre-peritoneal implantation of a bi-layered mesh for anatomical replacement of the damaged fascia. The second phase involved the implantation of the bi-layered Tensiflex mesh prosthesis for definitive and seamless augmentation of tensile strength in the myopectineal orifice of Fruchaud. Eighty-three percent of our patients consumed analgesics for 3 days (3% reported no pain on day 3); however, by day 5, 86% reported pain intensity scores lower than 5. The median number of lost workdays was 7. Most importantly, the primary endpoint of 100% recurrence-free outcomes was met, as were the secondary endpoints (minimal pain, morbidity, and loss of workdays).

Official Title
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Former Chairman Department of Surgery St.Joseph Mercy Oakland Pontiac Former Clinical Associate Professor Surgery Wayne State University,Detroit

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Device: Wing shaped Tensiflex prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients with confirmed groin hernia of both sexes. Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All patients with confirmed inguinal hernias of all types
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Phase 1:Study role tissue tensile strength<br>The tensile strength of the orifice of Frauchad was augmented by implantation of a Accordion fold shaped prosthesis. | Device: Wing shaped Tensiflex prosthesis<br>* Curative inguinal hernia repair techniqque<br>|
| Other: Phase 2:Curative implantation of a custom designed bio-mechanically compatible Tensiflex prosthesis<br>The wing shaped custom designed tensiflex prosthesis in the groin was impanted as a curative technique since it provided seamless augmenation of the tensile tissue strength. | Device: Wing shaped Tensiflex prosthesis<br>* Curative inguinal hernia repair techniqque<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free outcome | The prospective study of 486 patients includes implantation of the specially designed Tensiflex mesh prosthesis in117 patients for seamless augmentation of the tensile strength,has rendered 100% recurrence free oucomes. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tensile strength augmentation.