Synthetic cyanoacrylic glue in the prevention of post-operative lymphocele after pelvic lymphadenectomy in patients with uterine malignancies: A prospective, single-blind, preliminary study.

ABSTRACT

OBJECTIVES: Lymphoceles are among the most common post-operative complications of pelvic lymphadenectomy, with a reported incidence of 1% to 29% in gynecology oncology. Several studies evaluated the effectiveness of biological glues on reducing lymphoceles, but no data on gynecological patients are available. We evaluated the effectiveness of cyanoacrylic glues (n-butyl cyanoacrylate) (Glubran 2 - GEM s.r.l., Italy) in preventing lymphocele on 30 patients who underwent pelvic lymphadenectomy for endometrial or cervical cancer. METHODS: Single-blind prospective randomized study. Patients were divided into 2 groups pelvic lymphadenectomy plus n-butyl cyanoacrylate (treatment group 44 patients) and pelvic lymphadenectomy without n-butyl cyanoacrylate (control group 44 patients). Primary endpoint was incidence of pelvic lymphocele in the two groups 30 days after surgery, and evaluated with pelvic ultrasound and RMI examination. Secondary endpoints evaluated drainage volume of lymphorrhea 36, 48, 72 and 96 h after surgery. RESULTS: 15% in the treatment group and 36.6% in the control group had lymphocele 1month after the procedure (p<0.03; RR 0.4 [95% CI 0.152-0.999]). Concerning the secondary outcome in group A the amount of lymphorrhea presented a constant significant decrease during evaluation; on the contrary, in group B, after an initial decrease at 48 h, the amount of lymphorrhea remained unchanged; at all considered times the amount of lymphorrhea resulted significantly greater in controls. CONCLUSION: Intraoperative application of n-butyl cyanoacrylate seems to reduce lymph production after pelvic lymphadenectomy, providing a useful additional treatment option for reducing drainage volume and preventing lymphocele development after pelvic lymphadenectomy.