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
  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:


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
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, see Learn About Clinical Studies.

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:
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 August 28, 2014