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

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ClinicalTrials.gov Identifier: NCT00323674
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Active, not recruiting
First Posted : May 9, 2006
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
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 or disease Intervention/treatment Phase
Hernia, Inguinal Device: Polysoft Mesh Device: Light Weight Mesh Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2006
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight Hernia

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Percentage of relapse [ Time Frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. ]
  2. Postoperative pain assessment [ Time Frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. ]
  3. Duration to full recovery (able to do all activities) [ Time Frame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic hernia inguinalis
  • > 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323674


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

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00323674     History of Changes
Other Study ID Numbers: 2006/080
First Posted: May 9, 2006    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
Hernia Inguinalis

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