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

Universitaire Ziekenhuizen KU Leuven59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Inguinal Hernia

Interventions

laparoscopic (TEP) inguinal hernia repairPROCEDURE

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

lightweight TiMeshDEVICE

lightweight VyproIIDEVICE

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary, unilateral or bilateral, inguinal hernia patients * Informed consent Exclusion Criteria: * Sterilized patients

Locations (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Outcomes

Primary Outcomes

Male fertility aspects

Time frame: 12 months

Secondary Outcomes

Quality of life, pain development, recurrence

Time frame: 1, 3, 6 and 12 months

Data from ClinicalTrials.gov

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