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

U

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Conditions

Inguinal Hernia

Treatments

Device: lightweight VyproII
Device: Heavyweight Marlex
Procedure: laparoscopic (TEP) inguinal hernia repair
Device: lightweight TiMesh

Study type

Interventional

Funder types

Other

Identifiers

NCT00925067
G.0457.04N

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Sterilized patients

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

59 participants in 3 patient groups

lightweight TiMesh
Experimental group
Treatment:
Device: lightweight TiMesh
Procedure: laparoscopic (TEP) inguinal hernia repair
lightweight VyproII
Experimental group
Treatment:
Device: lightweight VyproII
Procedure: laparoscopic (TEP) inguinal hernia repair
Heavyweight Marlex
Experimental group
Treatment:
Device: Heavyweight Marlex
Procedure: laparoscopic (TEP) inguinal hernia repair

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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