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OpenTrials
Completed

NCT Number: NCT01070693

Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair

This randomised prospective study was designed to compare the convalescence and the long-term sequelae in inguinal hernia repair with either a bilayer mesh as devised by Gilbert (Prolene Hernia System®) or an onlay mesh applied according to Lichtenstein.

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Key information

Conditions

Chronic Pain Disease Attributes Hernia Hernia, Abdominal Hernia, Inguinal Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Recurrence Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital

Espoo, 07430, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Uni- or bilateral
  • Primary or recurrent

Exclusion criteria

  • body-mass index over 40kg/m2, severe co-morbidities

Treatment and study plan

Open mesh inguinal hernia repair

Procedure

Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique

Prolene Hernia System

Device

Prolene Hernia System

Lichtenstein Technique

Procedure

Lichtenstein technique

Primary outcomes

  1. Long-term Sequelae

    Time frame: 5 years

    Any pain at five years

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair

Important dates

Study start
2001
Primary completion
2005
Study completion
2009
First posted
Feb 18, 2010
Registry last updated
Jan 16, 2014

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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