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

Inguinal Hernia Clinical Trial

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

Status Completed

Clinical Trial 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."

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

• NCT number: NCT04764760
• Study type: Interventional
• Source: St. Joseph Mercy Oakland Hospital
• Status: Completed
• Phase: N/A
• Start date: January 1987
• Completion date: February 2001