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

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Completed
• CT.gov ID: NCT00925067
• Collaborator: Fund for Scientific Research, Flanders, Belgium (Other), Agentschap voor Innovatie door Wetenschap en Technologie (Other)
• Enrollment: 59
• Location: 1
• Arms: 3
• Duration (Months): 74
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inguinal Hernia	Procedure: laparoscopic (TEP) inguinal hernia repair; Device: lightweight TiMesh; Device: lightweight VyproII; Device: Heavyweight Marlex	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects
• Study Start Date: Apr 1, 2003
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lightweight TiMesh	Procedure: 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); Device: lightweight TiMesh
Experimental: lightweight VyproII	Procedure: 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); Device: lightweight VyproII
Experimental: Heavyweight Marlex	Procedure: 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); Device: Heavyweight Marlex

Outcome Measures

Primary Outcome Measures

1. Male fertility aspects [12 months]

Secondary Outcome Measures

1. Quality of life, pain development, recurrence [1, 3, 6 and 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Primary, unilateral or bilateral, inguinal hernia patients

• Informed consent

Exclusion Criteria:

• Sterilized patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Leuven	Leuven	Vlaams-Brabant	Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven
• Fund for Scientific Research, Flanders, Belgium
• Agentschap voor Innovatie door Wetenschap en Technologie

Investigators

• Principal Investigator: Marc Miserez, MD, PhD, Universitaire Ziekenhuizen Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00925067
• Other Study ID Numbers: G.0457.04N
• First Posted: Jun 19, 2009
• Last Update Posted: Jun 19, 2009
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: Inguinal hernia; Laparoscopic repair; Prostheses; Male fertility
• Additional relevant MeSH terms: Hernia; Hernia, Inguinal

Study Results

No Results Posted as of Jun 19, 2009