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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014