Back to resultsEffects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
laparoscopic (TEP) inguinal hernia repair
lightweight TiMesh
lightweight VyproII
Heavyweight Marlex
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring Inguinal hernia, Laparoscopic repair, Prostheses, Male fertility
Eligibility Criteria
Inclusion Criteria:
- Primary, unilateral or bilateral, inguinal hernia patients
- Informed consent
Exclusion Criteria:
- Sterilized patients
Sites / Locations
- University Hospitals Leuven
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
lightweight TiMesh
lightweight VyproII
Heavyweight Marlex
Arm Description
Outcomes
Primary Outcome Measures
Male fertility aspects
Secondary Outcome Measures
Quality of life, pain development, recurrence
Full Information
NCT ID
NCT00925067
First Posted
June 18, 2009
Last Updated
June 18, 2009
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Fund for Scientific Research, Flanders, Belgium, Agentschap voor Innovatie door Wetenschap en Technologie
1. Study Identification
Unique Protocol Identification Number
NCT00925067
Brief Title
Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects
Official Title
Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Fund for Scientific Research, Flanders, Belgium, Agentschap voor Innovatie door Wetenschap en Technologie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Inguinal hernia, Laparoscopic repair, Prostheses, Male fertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lightweight TiMesh
Arm Type
Experimental
Arm Title
lightweight VyproII
Arm Type
Experimental
Arm Title
Heavyweight Marlex
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
laparoscopic (TEP) inguinal hernia repair
Intervention Description
laparoscopic inguinal hernia repair with a standard heavyweight Marlex (control group) prosthesis or new generation lightweight VyproII and TiMesh prostheses (study group)
Intervention Type
Device
Intervention Name(s)
lightweight TiMesh
Intervention Type
Device
Intervention Name(s)
lightweight VyproII
Intervention Type
Device
Intervention Name(s)
Heavyweight Marlex
Primary Outcome Measure Information:
Title
Male fertility aspects
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life, pain development, recurrence
Time Frame
1, 3, 6 and 12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary, unilateral or bilateral, inguinal hernia patients
Informed consent
Exclusion Criteria:
Sterilized patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Miserez, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
20622657
Citation
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.
Results Reference
derived
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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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