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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00925067

Enrollment

Registered

2009-06-19

Start date

2003-04-30

Completion date

2009-06-30

Last updated

2009-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

Inguinal hernia, Laparoscopic repair, Prostheses, Male fertility

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.

Interventions

PROCEDURElaparoscopic (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)

DEVICElightweight TiMesh

DEVICElightweight VyproII

DEVICEHeavyweight Marlex

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Sterilized patients

Design outcomes

Primary

Measure	Time frame
Male fertility aspects	12 months

Secondary

Measure	Time frame
Quality of life, pain development, recurrence	1, 3, 6 and 12 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026