Pain after laparascopic bilateral hernioplasty : Early results of a prospective randomized double-blind study comparing fibrin versus staples

Abstract

Background: The use of fibrin for mesh fixation in laparascopic hernioplasty has theoretical advantages in that it could result in reducing postoperative pain. The objective of this study is to demonstrate this improvement in postoperative pain with the highest level of evidence possible.

Methods: Unicenter single surgeon prospective randomized double-blind study of transabdominal preperitoneal (TAPP) bilateral hernioplasties comparing autologous fibrin sealant (FG) used for mesh fixation on one side and staples (SG) on the other. Data were collected regarding anthropometric measures, costs, complications and pain evaluation at postoperative days 7, 30 and 180 using a visual analogue scale. The patients were also asked to answer the following simple question: "On which side do you have more pain?"

Results: Twenty-two eligible patients were included in the study. Both groups were comparable. The operating time was significantly longer (30 min more) in the FG. The incidence of seroma was similar in both groups, and that of hematoma was higher in the SG (0 vs. 9.1%). At 1 week, the visual analogue scale scores were significantly lower in the FG (median: 1.7 vs. 4.5; MWU:103.5, p < 0.05). At 1 month, this difference became clinical and statistically insignificant. 72.7% of the patients referred more pain on the side with staples at 1 week, 38% at 1 month, and 0% at 6 months (after patients with hernia recurrence were excluded). The recurrence rate was higher in the FG (9.9 vs. 13.6%). A hernia in the FG cost 200 Euros more than that in the SG, or even more if a complete economic study is considered.

Conclusions: The use of fibrin produces less postoperative pain in the first week, but prolongs operating time and increases costs. Moreover, there appears to be a higher recurrence rate and a lower incidence of hematoma, while the incidence of seroma remains unchanged.