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

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ClinicalTrials.gov Identifier: NCT00925067
Recruitment Status : Completed
First Posted : June 19, 2009
Last Update Posted : June 19, 2009
Sponsor:
Collaborators:
Fund for Scientific Research, Flanders, Belgium
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by:
Universitaire Ziekenhuizen Leuven

June 18, 2009
June 19, 2009
June 19, 2009
April 2003
October 2007   (Final data collection date for primary outcome measure)
Male fertility aspects [ Time Frame: 12 months ]
Same as current
No Changes Posted
Quality of life, pain development, recurrence [ Time Frame: 1, 3, 6 and 12 months ]
Same as current
Not Provided
Not Provided
 
Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Inguinal Hernia
  • Procedure: laparoscopic (TEP) inguinal hernia repair
    laparoscopic inguinal hernia repair with a standard heavyweight Marlex (control group) prosthesis or new generation lightweight VyproII and TiMesh prostheses (study group)
  • Device: lightweight TiMesh
  • Device: lightweight VyproII
  • Device: Heavyweight Marlex
  • Experimental: lightweight TiMesh
    Interventions:
    • Procedure: laparoscopic (TEP) inguinal hernia repair
    • Device: lightweight TiMesh
  • Experimental: lightweight VyproII
    Interventions:
    • Procedure: laparoscopic (TEP) inguinal hernia repair
    • Device: lightweight VyproII
  • Experimental: Heavyweight Marlex
    Interventions:
    • Procedure: laparoscopic (TEP) inguinal hernia repair
    • Device: Heavyweight Marlex
Peeters E, Spiessens C, Oyen R, De Wever L, Vanderschueren D, Penninckx F, Miserez M. Laparoscopic inguinal hernia repair in men with lightweight meshes may significantly impair sperm motility: a randomized controlled trial. Ann Surg. 2010 Aug;252(2):240-6. doi: 10.1097/SLA.0b013e3181e8fac5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
Same as current
June 2009
October 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Sterilized patients
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00925067
G.0457.04N
No
Not Provided
Not Provided
Marc Miserez, University Hospitals Leuven
Universitaire Ziekenhuizen Leuven
  • Fund for Scientific Research, Flanders, Belgium
  • Agentschap voor Innovatie door Wetenschap en Technologie
Principal Investigator: Marc Miserez, MD, PhD University Hospitals Leuven
Universitaire Ziekenhuizen Leuven
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP