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OpenTrials
Completed

NCT Number: NCT00323674

Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh

This is a prospective randomized study to evaluate the recovery of a hernia inguinalis by a minimally invasive open preperitoneal surgery with polysoft mesh versus a classic open surgery according to modified Lichtenstein procedure with light weight mesh.

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Key information

Conditions

Hernia, Inguinal Hernia Hernia, Abdominal 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

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptomatic hernia inguinalis
  • > 18 years

Treatment and study plan

Polysoft Mesh

Device

Polysoft Mesh is used.

Light Weight Mesh

Device

Light Weight Mesh is used.

Primary outcomes

  1. Percentage of relapse

    Time frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.

  2. Postoperative pain assessment

    Time frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.

  3. Duration to full recovery (able to do all activities)

    Time frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Prospective Randomized Study to Evaluate the Recovery of a Hernia Inguinalis by a Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery According to Modified Lichtenstein Procedure With Light Weight Mesh

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
May 9, 2006
Registry last updated
Sep 5, 2023

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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