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

NCT ID: NCT04764760

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 486 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1987-01-31
• Study Completion Date: 2001-02-28

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1:Study role tissue tensile strength

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

Group Type: OTHER

Wing shaped Tensiflex prosthesis

Intervention Type: DEVICE

Curative inguinal hernia repair techniqque

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

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.

Group Type: OTHER

Wing shaped Tensiflex prosthesis

Intervention Type: DEVICE

Curative inguinal hernia repair techniqque

Interventions

Wing shaped Tensiflex prosthesis

Curative inguinal hernia repair techniqque

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• all patients with confirmed groin hernia of both sexes.

Exclusion Criteria

• none

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Joseph Mercy Oakland Hospital

OTHER

Sponsor Role: lead

Responsible Party

Narendra Tyagi MD

Former Chairman of surgery St. Joseph Mercy Oakland Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Narendra Tyagi, MD FACS

Role: PRINCIPAL_INVESTIGATOR

St.Joseph Mercy Oakland Pontiac

Locations

St.Joseph Mercy Oakland Pontiac

Pontiac, Michigan, United States

Countries

United States

Other Identifiers

StJosephMOH

Identifier Type: -

Identifier Source: org_study_id