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OpenTrials
Completed

NCT Number: NCT00925067

Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects

A randomized, prospective clinical trial analyzing whether the use of lightweight prostheses during laparoscopic inguinal hernia repair of male patients could have a beneficial effect on postoperative discomfort, chronic pain development, recurrence and male fertility aspects.

Completed

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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–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary, unilateral or bilateral, inguinal hernia patients
  • Informed consent

Exclusion criteria

  • Sterilized patients

Treatment and study plan

laparoscopic (TEP) inguinal hernia repair

Procedure

laparoscopic inguinal hernia repair with a standard heavyweight Marlex (control group) prosthesis or new generation lightweight VyproII and TiMesh prostheses (study group)

lightweight TiMesh

Device

lightweight VyproII

Device

Heavyweight Marlex

Device

Primary outcomes

  1. Male fertility aspects

    Time frame: 12 months

Secondary outcomes

  1. Quality of life, pain development, recurrence

    Time frame: 1, 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Agentschap voor Innovatie door Wetenschap en Technologie
  • Fund for Scientific Research, Flanders, Belgium

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2009
First posted
Jun 19, 2009
Registry last updated
Jun 19, 2009

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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