Hemostatic Efficacy of TachoSil in Loop Electrosurgical Excisional Procedure: A Prospective Randomized Controlled Study.

Objective: The aim of the study was to evaluate the hemostatic efficacy of the fibrin sealant patch (TachoSil) after loop electrosurgical excision (LEEP) and its influence on other complications and quality of life (QoL).

Materials and methods: This single-blind, prospective, randomized study involved patients undergoing LEEP with or without TachoSil (1:1) between August 2014 and August 2015 in Asan Medical Center, Korea. Primary outcome measures were bleeding duration and the frequency of additional treatment owing to vaginal bleeding within 2 weeks after LEEP. Secondary outcome measures were vaginal bleeding volume using pictorial blood loss assessment chart (PBAC) score, the amount of vaginal discharge, the frequency of external genitalia, vaginal, and cervical infections within 2 weeks after LEEP, and changes in QoL.

Results: Of the 140 patients enrolled, 126 (90.0%) were successfully followed up and analyzed. The median vaginal bleeding duration and frequency of additional treatment owing to vaginal bleeding showed no significant difference in the TachoSil applied and nonapplied groups ( p = .96 and p = .61, respectively). In addition, no significant difference was also observed in vaginal bleeding volume between 2 groups ( p = .64). In subgroup analysis for patients who underwent large LEEP (the longest dimension of ≥2 cm), significant improvement was observed at physical functioning in QoL at 2-3 ( p = .03) and 6 weeks ( p = .03) after LEEP of the TachoSil applied group, compared to the nonapplied group.

Conclusions: TachoSil did not demonstrate significant hemostatic efficacy after LEEP. However, TachoSil improved patient recognition on physical function in patients who underwent large LEEP.