Pontiac, Michigan 48341

  • Inguinal Hernia

Purpose:

"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."


Study summary:

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).


Criteria:

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


NCT ID:

NCT04764760


Primary Contact:

Principal Investigator
Narendra Tyagi, MD FACS
St.Joseph Mercy Oakland Pontiac


Backup Contact:

N/A


Location Contact:

Pontiac, Michigan 48341
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 24, 2021

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