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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2023
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Polysoft Mesh
Polysoft Mesh is used.
Light Weight Mesh
Light Weight Mesh is used.

Locations

Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

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.
See also
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