NCT00925067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2009

Completed
Last Updated

June 19, 2009

Status Verified

June 1, 2009

Enrollment Period

4.5 years

First QC Date

June 18, 2009

Last Update Submit

June 18, 2009

Conditions

Inguinal Hernia

Keywords

Inguinal herniaLaparoscopic repairProsthesesMale fertility

Outcome Measures

Primary Outcomes (1)

  • Male fertility aspects

    12 months

Secondary Outcomes (1)

  • Quality of life, pain development, recurrence

    1, 3, 6 and 12 months

Study Arms (3)

lightweight TiMesh

EXPERIMENTAL
Procedure: laparoscopic (TEP) inguinal hernia repairDevice: lightweight TiMesh

lightweight VyproII

EXPERIMENTAL
Procedure: laparoscopic (TEP) inguinal hernia repairDevice: lightweight VyproII

Heavyweight Marlex

EXPERIMENTAL
Procedure: laparoscopic (TEP) inguinal hernia repairDevice: Heavyweight Marlex

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)

Heavyweight Marlexlightweight TiMeshlightweight VyproII
lightweight TiMeshDEVICE
lightweight TiMesh
lightweight VyproIIDEVICE
lightweight VyproII
Heavyweight MarlexDEVICE
Heavyweight Marlex

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Sterilized patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 20622657DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Laparoscopytetraethylpyrazine

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Marc Miserez, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2009

First Posted

June 19, 2009

Study Start

April 1, 2003

Primary Completion

October 1, 2007

Study Completion

June 1, 2009

Last Updated

June 19, 2009

Record last verified: 2009-06

Locations

BE(1)