Comparison of Self-Fixating vs Non-Fixating Hernia Mesh

Overview

The purpose of this study is to determine if self-fixating polyester mesh will have lower incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when used for laparoscopic inguinal hernia repair.

Full Title of Study: “A Randomized Controlled Study of Self Fixating Mesh Versus Non Fixating Polyester Mesh for Laparoscopic Inguinal Hernia Repair”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 10, 2017

Detailed Description

This is a randomized, blinded comparison of self-gripping mesh and standard polyester mesh for laparoscopic, primary inguinal hernia repair performed in a Totally ExtraPeritoneal (TEP) fashion.

Interventions

  • Procedure: Use of self-fixating mesh for inguinal hernia repair
    • Parietex ProGrip will be used to repair inguinal hernia
  • Procedure: Use of non-fixating mesh for inguinal hernia repair
    • Parietex Anatomic mesh will be used to repair inguinal hernias.
  • Procedure: Absorbable tacks may be used in hernias >2cm
    • Patients randomized to the Parietex ProGrip study group will be further randomized to either receive absorbable tacks or no tacks if the hernia measures >2cm

Arms, Groups and Cohorts

  • Active Comparator: Self-Fixating Hernia Mesh
    • Self-fixating polyester mesh will be used for laparoscopic inguinal hernia repair.
  • Placebo Comparator: Non-Fixating Hernia Mesh
    • Non-fixating polyester mesh will be used for laparoscopic hernia repair.

Clinical Trial Outcome Measures

Primary Measures

  • Chronic postoperative pain
    • Time Frame: 1 year

Secondary Measures

  • Incidence of hernia recurrence
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • > 18 years – ASA Classification I, II, III – scheduled for elective TEP inguinal hernia repair Exclusion Criteria:

  • ASA Classification IV or greater – needing emergency surgery – known history of narcotic dependence – undergoing bilateral inguinal or combined umbilical hernia repair – undergoing other procedures during same anesthetic – undergoing recurrent inguinal hernia repair

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NorthShore University HealthSystem
  • Collaborator
    • Medtronic – MITG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • John Linn, MD, Principal Investigator, NorthShore University HealthSystem

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