Hernia, Inguinal
Conditions
Brief summary
The purpose of this study is to compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The investigators will also be assessing the cost for the procedures and hospital care as well as the cost for sick-leave depending on procedure performed. The study hypothesis is that the laparoscopic approach will be associated with less long term post operative pain.
Interventions
PROCEDUREMesh repair for primary inguinal hernia
Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh
Sponsors
Uppsala County Council, Sweden
Uppsala University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Unilateral inguinal hernia * suitable for open mesh repair in local anesthesia as well as laparoscopic repair * ASA score I-III * informed consent
Exclusion criteria
* ASA score IV (not suitable for TEP) * bilateral hernias (laparoscopic repair preferable) * recurrent hernia (primary repair affects preferable treatment) * large scrotal hernias (not suitable for local anesthesia) * earlier open lower abdominal surgery, aside from appendectomy (scarring may be a hindrance for TEP)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| long-term post operative pain | 6 wks, 1 year |
Secondary
| Measure | Time frame |
|---|---|
| cost-effectiveness of the separate procedures | 6wks, 1year |
Countries
Sweden
Outcome results
None listed