Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location information
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Layout table for investigator information
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
Additional Information:
Layout table for additonal information
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00323674    
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:
Layout table for MeSH terms
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal