Back to resultsMinimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh
Primary Purpose
Hernia, Inguinal
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Polysoft Mesh
Light Weight Mesh
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Inguinal focused on measuring Hernia Inguinalis
Eligibility Criteria
Inclusion Criteria: Symptomatic hernia inguinalis > 18 years
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Light Weight Mesh
Polysoft Mesh
Arm Description
Outcomes
Primary Outcome Measures
Percentage of relapse
Postoperative pain assessment
Duration to full recovery (able to do all activities)
Secondary Outcome Measures
Full Information
NCT ID
NCT00323674
First Posted
May 7, 2006
Last Updated
August 31, 2023
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00323674
Brief Title
Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh
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 Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 2006 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
Hernia Inguinalis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Light Weight Mesh
Arm Type
Active Comparator
Arm Title
Polysoft Mesh
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Polysoft Mesh
Intervention Description
Polysoft Mesh is used.
Intervention Type
Device
Intervention Name(s)
Light Weight Mesh
Intervention Description
Light Weight Mesh is used.
Primary Outcome Measure Information:
Title
Percentage of relapse
Time Frame
Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
Title
Postoperative pain assessment
Time Frame
Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
Title
Duration to full recovery (able to do all activities)
Time Frame
Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic hernia inguinalis
> 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Berrevoet, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh
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