Efficacy of a collagen-fibrin sealant patch (TachoSil®) as adjuvant treatment in the inguinofemoral lymphadenectomy for vulvar cancer: a double-blind randomized-controlled trial.

PURPOSE: To evaluate the effect of a collagen-fibrin sealant patch (TachoSil®) in preventing postoperative complications after inguinofemoral lymphadenectomy for vulvar cancer.

METHODS: Double-blind randomized-controlled trial on consecutive patients undergoing bilateral inguinofemoral lymphadenectomy for vulvar cancer. Intraoperatively, inguinofemoral areas were randomized: one was treated with TachoSil®, while the contralateral had standard closure without collagen-fibrin sealant patch. Surgical outcomes, amount of drainage volume, duration of drain placement, and any postoperative complication (vulvar wound dehiscence, inguinal wound dehiscence, cellulitis, lymphangitis, lymphoceles, and hematoma) were recorded. Leg measurements were taken preoperatively and during postoperative follow-up until 6 months to evaluate lymphedema.

RESULTS: A total of 19 patients were enrolled and 38 inguinofemoral dissections were performed. There was no significant difference between the investigational and control arm in the amount of drainage volume (p = 0.976), and duration of drain placement (p = 0.793). The postoperative complications, excluding lymphedema, were 10/19 (53%) in investigational arm and 9/19 (47%) in control arm (p = 0.74). At the end of follow-up, the prevalence of grade 1 lymphedema was 44.4% and 50% in investigational and control arm, respectively (p = 0.744); grade 2 and 3 lymphedema had a prevalence of 33.3% in both arms (p = 1).

CONCLUSION: Application of TachoSil® does not seem to improve postoperative lymphorrhagia nor to reduce the incidence of postoperative complications in patients undergoing inguinofemoral lymphadenectomy for vulvar cancer. Considering this point, it would be useful to identify additional strategies in inguinofemoral dissection for the prevention of these complications.