The investigators want to evaluate the effect of suturing the mesh versus using a self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain.
Pain is a frequent problem after open inguinal hernia repair. The most frequent operative technique for inguinal hernia repair in adults is the Lichtenstein mesh repair, where a polypropylene mesh is sutured to the tissue in the inguinal region. We therefore want to evaluate the effect of suture for mesh fixation on the occurrence of chronic pain 12 months after operation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
334
Bispebjerg Hospital
Copenhagen, Copenhaven, Denmark
Frederikshavn Hospital
Frederikshavn, Frederikshavn, Denmark
Gentofte Hospital
Gentofte Municipality, Hellerup, Denmark
Randers Hospital
Randers, Randers, Denmark
Pain, Numbness and Discomfort in the Groin
The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit.
Time frame: 12 months after surgery
Recurrence
recurrence means recurrence of the hernia defined as a new lump in the inguinal region diagnosed by a surgeon to be a new inguinal hernia.
Time frame: 12 months after surgery
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Nyborg Hospital
Nyborg, Svendborg, Denmark