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

"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 Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Device: Wing shaped Tensiflex prosthesis

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).

• Study Type: Interventional
• Enrollment (Actual): 486
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Pontiac, Michigan, United States, 48341
      • St.Joseph Mercy Oakland Pontiac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all patients with confirmed groin hernia of both sexes.

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Device: Wing shaped Tensiflex prosthesis; Curative inguinal hernia repair techniqque
OTHER: 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.	Device: Wing shaped Tensiflex prosthesis; Curative inguinal hernia repair techniqque

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: St. Joseph Mercy Oakland Hospital
• Investigators: Principal Investigator: Narendra Tyagi, MD FACS, St.Joseph Mercy Oakland Pontiac

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 1987
• Primary Completion (ACTUAL): January 1, 2001
• Study Completion (ACTUAL): February 1, 2001

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (ACTUAL): February 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: tensile strength augmentation.
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: StJosephMOH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD
• IPD Sharing Time Frame: Starting immediately after publication
• IPD Sharing Access Criteria: All surgeons
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No