Pain after laparascopic bilateral hernioplasty : Early results of a prospective randomized double-blind study comparing fibrin versus staples.
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.
Boldo
E
E
Surgery, Consorcio Hospitalario Provincial Castellon, Castellon, Castellon, Spain. eboldo@yahoo.com
Armelles
Andres
A
Perez de Lucia
Guillermo
G
Martin
Felix
F
Aracil
Juan Pablo
JP
Miralles
Juan Manuel
JM
Martinez
David
D
Escrig
Javier
J
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005337:Fibrin / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D017048:Health Care Costs; D006552:Hernia, Inguinal / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects* / Q000191:economics / Q000379:methods; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010149:Postoperative Pain / Q000209:etiology*; D011446:Prospective Studies; D012008:Recurrence; D049291:Seroma / Q000209:etiology; D013526:Surgical Mesh / Q000191:economics; D017792:Surgical Stapling / Q000009:adverse effects* / Q000191:economics; D014014:Tissue Adhesives / Q000009:adverse effects* / Q000191:economics / Q000627:therapeutic use; D016896:Treatment Outcome
D014014:Tissue Adhesives; D005337:Fibrin