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

St. Joseph Mercy Oakland Hospital

Status: Completed

Conditions: Inguinal Hernia

Treatments: Device: Wing shaped Tensiflex prosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT04764760

StJosephMOH

Details and patient eligibility

About

"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."

Full 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).

Enrollment: 486 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• all patients with confirmed groin hernia of both sexes.

Exclusion criteria

• none

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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486 participants in 2 patient groups

Phase 1:Study role tissue tensile strength

Other group

Description:

The tensile strength of the orifice of Frauchad was augmented by implantation of a Accordion fold shaped prosthesis.

Treatment:

Device: Wing shaped Tensiflex prosthesis

Phase 2:Curative implantation of a custom designed bio-mechanically compatible Tensiflex prosthesis

Other group

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.

Treatment:

Device: Wing shaped Tensiflex prosthesis