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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764760
• Other study ID #: StJosephMOH
• Status: Completed
• Phase: N/A
• Start date: January 1987
• Est. completion date: February 2001

Study information

• Verified date: February 2021
• Source: St. Joseph Mercy Oakland Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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."

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: February 2001
• Est. primary completion date: January 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• all patients with confirmed groin hernia of both sexes.

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Device:
• Wing shaped Tensiflex prosthesis
Curative inguinal hernia repair techniqque

Locations

Country	Name	City	State
United States	St.Joseph Mercy Oakland Pontiac	Pontiac	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph Mercy Oakland Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence free outcome	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.	5 years