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NCT00925067 Clinical Trial

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

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00925067
Other study ID # G.0457.04N
Secondary ID
Status Completed
Phase N/A
First received June 18, 2009
Last updated June 18, 2009
Start date April 2003
Est. completion date June 2009

Study information
Verified date June 2009
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 59
Est. completion date June 2009
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Primary, unilateral or bilateral, inguinal hernia patients

- Informed consent

Exclusion Criteria:

- Sterilized patients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

• lightweight VyproII

• Heavyweight Marlex

Locations
Country Name City State
Belgium University Hospitals Leuven Leuven Vlaams-Brabant

Sponsors (3)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven Agentschap voor Innovatie door Wetenschap en Technologie, Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Male fertility aspects 12 months No
Secondary Quality of life, pain development, recurrence 1, 3, 6 and 12 months No
See also
  Status Clinical Trial Phase
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Recruiting NCT03904888 - Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair N/A
Recruiting NCT03856710 - Self Fixating Versus Stapled Mesh for Laparoscopic Inguinal Hernia Repair N/A
Completed NCT02240550 - A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair N/A
Completed NCT01679353 - Comparison of Analgesic Effect of Magnesium Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Inguinal Hernia Repair N/A
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Recruiting NCT01450345 - Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain Phase 3
Active, not recruiting NCT00968773 - Rebound Hernia Repair Device Mesh Trial Phase 4
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Completed NCT01117337 - Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair Phase 4
Terminated NCT00226161 - Chronic Pain After Inguinal Herniorrhaphy N/A
Completed NCT05837013 - Open and Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia Versus General Anesthesia N/A
Recruiting NCT05058378 - Correlation Between Spinal Anesthesia and Perfusion Index
Completed NCT01637818 - Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair N/A
Recruiting NCT05879770 - Is the Use of Prolene as Sufficient as the Use of Wire in Shouldice Surgery to Keep the Recurrence Rate Low After One Year?
Completed NCT05159232 - Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial N/A
Completed NCT05107986 - Laparoscopy in Complicated Groin Hernia
Active, not recruiting NCT04328597 - Portuguese Inguinal Hernia Cohort (PINE) Study
Completed NCT04033055 - Antalgic Efficacy of CycloMesh™ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia. N/A