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Comparison of Self-Fixating vs Non-Fixating Hernia Mesh

Not Applicable
Completed
Conditions
Inguinal Hernia
Registration Number
NCT02062775
Lead Sponsor
NorthShore University HealthSystem
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
285
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Chronic postoperative pain1 year
Secondary Outcome Measures
NameTimeMethod
Incidence of hernia recurrence1 year

Trial Locations

Locations (1)

NorthShore University HealthSystem

🇺🇸

Evanston, Illinois, United States

NorthShore University HealthSystem
🇺🇸Evanston, Illinois, United States
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