A Pilot Study to Investigate the Efficacy of Fibrin Sealant (Tisseel®) in the Loop Electrosurgical Excision Procedure.

ABSTRACT

AIMS: The objective of the current study was to evaluate the efficacy and feasibility of fibrin sealant (Tisseel®) in the loop electrosurgical excision procedure (LEEP) for cervical intraepithelial neoplasia (CIN 2 or 3). METHODS: We designed a single-blind, prospective, randomized study in 40 consecutive women undergoing LEEP for CIN 2 or 3 at our institute. Two milliliters of fibrin sealant (Tisseel) was applied to the uterine cervix of 20 women immediately after LEEP surgery (treatment group). We evaluated abdominal pain, vaginal bleeding, vaginal discharge and impairment in daily living after 1 week using visual analogue scale questionnaires and compared the results with those of 20 women who did not receive fibrin sealant (control group). RESULTS: Among 40 women who returned for a follow-up 1 week after LEEP, 25 women (62.5%) reported at least one moderate to severe postprocedural symptom. The mean duration of moderate to severe vaginal bleeding and impairment in daily living during postoperative week 1 for the treatment group and the control group was 0.3 ± 0.80 versus 1.7 ± 2.36 days (p = 0.015) and 0.9 ± 1.37 versus 3.00 ± 2.62 days (p = 0.060), respectively. CONCLUSION: Intraoperative application of fibrin sealant (Tisseel) in LEEP can decrease postoperative vaginal bleeding and impairment in daily living.