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

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Device: Wing shaped Tensiflex prosthesis

• Registration Number: NCT04764760
• Lead Sponsor: St. Joseph Mercy Oakland Hospital

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).

Study Timeline

• Study Start: 1987-01
• Primary Completion: 2001-01
• Study Completion: 2001-02
• Status Verified: 2021-02
• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-18
• Last Update Submitted: 2021-02-18
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 486

Inclusion Criteria

• all patients with confirmed groin hernia of both sexes.

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 1:Study role tissue tensile strength	Wing shaped Tensiflex prosthesis	The tensile strength of the orifice of Frauchad was augmented by implantation of a Accordion fold shaped prosthesis.
Phase 2:Curative implantation of a custom designed bio-mechanically compatible Tensiflex prosthesis	Wing shaped Tensiflex 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.

Primary Outcome Measures

Name	Time	Method
Recurrence free outcome	5 years	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.

Trial Locations

Locations (1)

St.Joseph Mercy Oakland Pontiac; 🇺🇸 Pontiac, Michigan, United States