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

NCT ID: NCT00925067

Last Updated: 2009-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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lightweight TiMesh

Group Type EXPERIMENTAL

laparoscopic (TEP) inguinal hernia repair

Intervention Type PROCEDURE

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

lightweight TiMesh

Intervention Type DEVICE

lightweight VyproII

Group Type EXPERIMENTAL

laparoscopic (TEP) inguinal hernia repair

Intervention Type PROCEDURE

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

lightweight VyproII

Intervention Type DEVICE

Heavyweight Marlex

Group Type EXPERIMENTAL

laparoscopic (TEP) inguinal hernia repair

Intervention Type PROCEDURE

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

Heavyweight Marlex

Intervention Type DEVICE

Interventions

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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)

Intervention Type PROCEDURE

lightweight TiMesh

Intervention Type DEVICE

lightweight VyproII

Intervention Type DEVICE

Heavyweight Marlex

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Sterilized patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role collaborator

Agentschap voor Innovatie door Wetenschap en Technologie

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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University Hospitals Leuven

Principal Investigators

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Marc Miserez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 20622657 (View on PubMed)

Other Identifiers

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G.0457.04N

Identifier Type: -

Identifier Source: org_study_id

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