Pontiac, Michigan 48341

  • Inguinal Hernia

Purpose:

"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 summary:

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).


Criteria:

Inclusion Criteria: - all patients with confirmed groin hernia of both sexes. Exclusion Criteria: - none


Study is Available At:


Original ID:

StJosephMOH


NCT ID:

NCT04764760


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

20 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

St. Joseph Mercy Oakland Hospital


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

486


Enrollment Type:

Actual


Overall Contact Information

Official Name:Narendra Tyagi, MD FACS
Principal Investigator
St.Joseph Mercy Oakland Pontiac

Study Dates

Start Date:January 1987
Completion Date:February 2001
Completion Type:Actual
Primary Completion Date:January 2001
Primary Completion Type:Actual
Verification Date:February 2021
Last Changed Date:February 18, 2021
First Received Date:February 18, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:Recurrence free outcome
Time Frame:5 years
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Device
Name:Wing shaped Tensiflex prosthesis
Description:Curative inguinal hernia repair techniqque
Arm Name:Phase 1:Study role tissue tensile strength

Study Arms

Study Arm Type:Other
Arm Name:Phase 2:Curative implantation of a custom designed bio-mechanically compatible Tensiflex prosthesis
Description: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.
Study Arm Type:Other
Arm Name:Phase 1:Study role tissue tensile strength
Description:The tensile strength of the orifice of Frauchad was augmented by implantation of a Accordion fold shaped prosthesis.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:St. Joseph Mercy Oakland Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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