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OpenTrials
Completed

NCT Number: NCT02062775

Comparison of Self-Fixating vs Non-Fixating Hernia Mesh

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of self-fixating mesh for inguinal hernia repair

Procedure

Parietex ProGrip will be used to repair inguinal hernia

Other names: Parietex ProGrip

Use of non-fixating mesh for inguinal hernia repair

Procedure

Parietex Anatomic mesh will be used to repair inguinal hernias.

Other names: Parietex Anatomic

Absorbable tacks may be used in hernias >2cm

Procedure

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

Primary outcomes

  1. Chronic postoperative pain

    Time frame: 1 year

Secondary outcomes

  1. Incidence of hernia recurrence

    Time frame: 1 year

Other outcomes

  1. Post-Op adverse events related to mesh

    Time frame: 1 year

  2. Post-Op quality of life and pain scores

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

A Randomized Controlled Study of Self Fixating Mesh Versus Non Fixating Polyester Mesh for Laparoscopic Inguinal Hernia Repair

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 14, 2014
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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