Randomized Prospective Double-Blinded Study of Histoacryl™Mesh Fixation Compared to Conventional Non-absorbable Suture Fixation During Lichtenstein Hernioplasty

Hypothesis:

1. To use glue (instead of sutures) for mesh fixation during open hernioplasty causes a lower immediate postoperative pain.
2. The use of Histoacryl is associated to a lower postoperative complications rate.
3. The use of Histoacryl is not associated to a higher hernia recurrence rate.

Methods:

350 patients with inguinal hernia undergone Lichtenstein operation in day-case surgery setting. Mesh fixation is performed using 2 methods: cyanoacrylate glue: Histoacryl™ (n=175: Group H), and non-absorbable sutures: polypropylene 2/0 (n=175: Group S). Operative time and pain scores, immediate postoperative outcome are followed 1, 7, 30 days and 1 and 5 years postoperatively.

Surgeon doesn't know previously which fixation method will be used in each patient. This method (glue or sutures) is decided intraoperatively, when mesh is placed, using a blind randomization code (www.randomizer.org) Patients are discharged (day-case surgery) if adequate pain control, oral tolerance and spontaneous diuresis is achieved, and after examination by the surgeon in order to discard immediate complications. Postoperative oral treatment is prescribed to patients of both groups: dexketoprofen 25 mg/8 h + paracetamol 1 gr/8.