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Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00323674
First received: May 7, 2006
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

This is a prospective randomized study to evaluate the recovery of a hernia inguinalis by a minimally invasive open preperitoneal surgery with polysoft mesh versus a classic open surgery according to modified Lichtenstein procedure with light weight mesh.


Condition Intervention
Hernia, Inguinal
 Device: Polysoft Mesh
Device: Light Weight Mesh

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study to Evaluate the Recovery of a Hernia Inguinalis by a Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery According to Modified Lichtenstein Procedure With Light Weight Mesh

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Percentage of relapse [ Time Frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. ] [ Designated as safety issue: No ]
  • Postoperative pain assessment [ Time Frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. ] [ Designated as safety issue: No ]
  • Duration to full recovery (able to do all activities) [ Time Frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2006
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Light Weight Mesh Device: Light Weight Mesh
Light Weight Mesh is used.
Active Comparator: Polysoft Mesh Device: Polysoft Mesh
Polysoft Mesh is used.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic hernia inguinalis
  • > 18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323674

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
  More Information

Additional Information:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00323674     History of Changes
Other Study ID Numbers: 2006/080
Study First Received: May 7, 2006
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Hernia Inguinalis

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on June 18, 2013