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OpenTrials
Completed

NCT Number: NCT00184483

A Multi-site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair

Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total number of 4 clinical examinations. End point is postoperative pain and recurrences.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, 7006, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary unilateral groin hernia in adult

Exclusion criteria

  • recurrence warfarin treatment bilateral groin hernia

Treatment and study plan

Lichtenstein's operation

Procedure

Lichtenstein's operation to repair primary unilateral inguinal hernia

Prolene Hernia System

Procedure

Prolene Hernia System to repair primary unilateral inguinal hernia

Primary outcomes

  1. pain postoperative

    Time frame: 3 years

Secondary outcomes

  1. Recurrences after groin hernia repair

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Haraldsplass Deaconess Hospital
  • Sorlandet Hospital HF
  • Sykehuset Ostfold
  • Voss Sykehus

Registry information

Official study title

Randomized Multi Site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair.

Important dates

Study start
2001
Primary completion
2015
Study completion
2015
First posted
Sep 16, 2005
Registry last updated
Sep 10, 2020

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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