Efficacy of a Fibrin Sealant (Tissucol Duo) for the Preventionof Lymphocele after Laparoscopic Pelvic Lymphadenectomy:A Randomized Controlled Trial.

STUDY OBJECTIVE

To assess the efficacy of Tissucol Duo (Baxter AG, Vienna, Austria) fibrin sealant in decreasing the incidence of lymphocele (LC) after pelvic laparoscopic lymph node dissection using harmonic shears.

DESIGN

Randomized controlled trial (Canadian Task Force classification level I).

SETTING

Tertiary referral and educational center.

PATIENTS

Seventy-four patients randomized to the use of sealant per hemipelvis.

INTERVENTION

Fibrin sealant.

MEASUREMENTS AND MAIN RESULTS

After bilateral pelvic lymphadenectomy a fibrin sealant was used in 1 hemipelvis but not the other, applied in 41 patients (55.4%) to the left and 33 patients (44.6%) to the right hemipelvis. The primary outcome was the incidence of LC after surgery in symptomatic and asymptomatic patients. Imaging (ultrasound, computed tomography, and magnetic resonance) was performed to detect LC at 3, 6, and 12 months after surgery. Overall, 26 patients (35.1%) developed LC, and 4 were symptomatic (5.4%). Allowing patients to serve as their own treatment group and control, the hemipelvis treated with Tissucol Duo corresponding to the treatment group and that not treated to the control group, LCs were found in 17 (23%) and 14 (19%) cases, respectively, but the difference was not significant. The mean initial LC maximum diameter was 27.1 mm (standard deviaiotn, 35.2), and LCs tended to decrease in size during the first year to a mean of 8.7 mm.

CONCLUSION

Application of Tissucol Duo fibrin sealant after laparoscopic pelvic lymphadenectomy using ultrasonic shears does not decrease the occurrence of symptomatic or asymptomatic LC.