Hernia, Inguinal Clinical Trial
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
NCT number | NCT00323674 |
Other study ID # | 2006/080 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2006 |
Est. completion date | August 31, 2015 |
Verified date | August 2023 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 278 |
Est. completion date | August 31, 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Symptomatic hernia inguinalis - > 18 years |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Ghent | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of relapse | Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. | ||
Primary | Postoperative pain assessment | Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. | ||
Primary | Duration to full recovery (able to do all activities) | Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year. |
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