NCT04764760

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: St. Joseph Mercy Oakland Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

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).

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
DEVICE	Wing shaped Tensiflex prosthesis	Curative inguinal hernia repair techniqque

Timeline

• Start date: 1987-01-01
• Primary completion: 2001-01-01
• Completion: 2001-02-01
• First posted: 2021-02-21
• Last updated: 2021-02-21

Locations

1 site across 1 country: United States