Prospective randomized trial comparing sutured with sutureless mesh fixation for Lichtenstein hernia repair: long-term results.

BACKGROUND: Following Lichtenstein hernia repair, up to 25% of patients experience prolonged postoperative and chronic pain as well as discomfort in the groin. One of the underlying causes of these complaints are the compression or irritation of nerves by the sutures used to fixate the mesh. We compared the level and rate of chronic pain in patients operated with the classical Lichtenstein technique fixated by sutures to patients with sutureless mesh fixation technique.
METHODS: A two-armed randomized trial with 264 male patients was performed. After consent, patients were randomized preoperatively. For the fixation of the mesh we used either sutures with slow-absorbing material (PDS 2.0) (group I, n = 133) or tissue glue (Histoacryl) (group II, n = 131). Follow-up examinations were performed after 3, 12 months and after 5 years.
RESULTS: Patient characteristics in the two groups were similar. No cross-over between groups was observed. After 5 years, long-term follow-up could be completed for 59% of subjects. After 5 years, 10/85 (11.7%) patients in group I and 3/70 (4.2%) in group II suffered from chronic pain in the groin region (P = 0.108). The operation time was significantly shorter in group II (79 min vs 73 min, P = 0.01). One early recurrence occurred in group II (3 months). The recurrence rate was 0 and 0% after 12 months and 5.9% (5/85) and 10% (7/70) after 5 years in group I and group II, respectively (P = 0.379).
CONCLUSION: After 5 years, the two techniques of mesh fixation resulted in similar rates of chronic pain. Whereas recurrence rates were comparable, fixation of the mesh with tissue glue decreased operating room time significantly. Hence, suture less mesh fixation with Histoacryl is a sensible alternative to suture fixation and should be especially considered for patients prone to pain.

RCT Entities:   Population Interventions Outcomes