Status:
COMPLETED
Study Comparing Total Extraperitoneal Patch "TEP" Versus Lichtenstein According Chronic Pain
Lead Sponsor:
Skane University Hospital
Collaborating Sponsors:
Region Skane
Conditions:
Chronic Pain
Sexual Dysfunction
Eligibility:
MALE
30-75 years
Phase:
NA
Brief Summary
The purpose of this study is to se if there is a difference regarding chronic pain and sexual dysfunction one and tree years after laparoscopic un fixated preperitoneal mesh versus gold standard open ...
Detailed Description
Prospective randomized study comparing total extraperitoneal patch TEP versus open onlay mesh according to Lichtenstein in primary unilateral inguinal hernias in men between 30 to 75 years of age. Non...
Eligibility Criteria
Inclusion
- men between 30-75 years of age
- ASA class I-II
- primary unilateral inguinal hernia
Exclusion
- lower midline incision below linea arcuate
- large scrotal hernia
- previously or current abuse,mental disease
- obesity BMI \> 35
- another simultaneous operation
- nonreducible hernia
- severe pain in the groin without nonrelated to hernia
- contraindications to general anesthesia
- need of language translator
- liver cirrhosis or ascites
- spread cancer disease
- previously irradiation in the area
- lack of operations indication
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT00803985
Start Date
April 1 2008
End Date
March 1 2018
Last Update
December 20 2018
Active Locations (1)
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1
Regionala etikprövningsnämden i Lund, avd 2
Lund, Sweden, 221 00