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

This study has been completed.
Sponsor:
Collaborators:
Fund for Scientific Research, Flanders, Belgium
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00925067
First received: June 18, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Inguinal Hernia
Procedure: laparoscopic (TEP) inguinal hernia repair
Device: lightweight TiMesh
Device: lightweight VyproII
Device: Heavyweight Marlex

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Male fertility aspects [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life, pain development, recurrence [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: April 2003
Study Completion Date: June 2009
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lightweight TiMesh 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
Experimental: lightweight VyproII 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 VyproII
Experimental: Heavyweight Marlex 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: Heavyweight Marlex

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Sterilized patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925067

Locations
Belgium
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Fund for Scientific Research, Flanders, Belgium
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
Principal Investigator: Marc Miserez, MD, PhD University Hospitals Leuven
  More Information

No publications provided by Universitaire Ziekenhuizen Leuven

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marc Miserez, University Hospitals Leuven
ClinicalTrials.gov Identifier: NCT00925067     History of Changes
Other Study ID Numbers: G.0457.04N
Study First Received: June 18, 2009
Last Updated: June 18, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitaire Ziekenhuizen Leuven:
Inguinal hernia
Laparoscopic repair
Prostheses
Male fertility

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on April 17, 2014