Biomechanically Compatible,Minimally Invasive Technique for Recurrence Free Groin Hernia Repair
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wing shaped Tensiflex prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring tensile strength augmentation.
Eligibility Criteria
Inclusion Criteria:
- all patients with confirmed groin hernia of both sexes.
Exclusion Criteria:
- none
Sites / Locations
- St.Joseph Mercy Oakland Pontiac
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Phase 1:Study role tissue tensile strength
Phase 2:Curative implantation of a custom designed bio-mechanically compatible Tensiflex prosthesis
Arm Description
The tensile strength of the orifice of Frauchad was augmented by implantation of a Accordion fold shaped prosthesis.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04764760
First Posted
February 18, 2021
Last Updated
February 18, 2021
Sponsor
St. Joseph Mercy Oakland Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04764760
Brief Title
Biomechanically Compatible,Minimally Invasive Technique for Recurrence Free Groin Hernia Repair
Official Title
Former Chairman Department of Surgery St.Joseph Mercy Oakland Pontiac Former Clinical Associate Professor Surgery Wayne State University,Detroit
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1987 (Actual)
Primary Completion Date
January 2001 (Actual)
Study Completion Date
February 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph Mercy Oakland Hospital
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
"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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
tensile strength augmentation.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients with confirmed inguinal hernias of all types
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
486 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase 1:Study role tissue tensile strength
Arm Type
Other
Arm Description
The tensile strength of the orifice of Frauchad was augmented by implantation of a Accordion fold shaped prosthesis.
Arm Title
Phase 2:Curative implantation of a custom designed bio-mechanically compatible Tensiflex prosthesis
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Wing shaped Tensiflex prosthesis
Intervention Description
Curative inguinal hernia repair techniqque
Primary Outcome Measure Information:
Title
Recurrence free outcome
Description
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.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all patients with confirmed groin hernia of both sexes.
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narendra Tyagi, MD FACS
Organizational Affiliation
St.Joseph Mercy Oakland Pontiac
Official's Role
Principal Investigator
Facility Information:
Facility Name
St.Joseph Mercy Oakland Pontiac
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD
IPD Sharing Time Frame
Starting immediately after publication
IPD Sharing Access Criteria
All surgeons
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Biomechanically Compatible,Minimally Invasive Technique for Recurrence Free Groin Hernia Repair
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