A prospective, randomized clinical comparison between UltraCision and the novel sealing and cutting device BiCision in patients with laparoscopic supracervical hysterectomy

摘要

Background: Various surgical procedures for hysterectomy exist; with laparoscopic supracervical hysterectomy (LASH) becoming an established option in recent years. Therefore, energy-based technologies for rapid tissue sealing and cutting are in the focus of surgeons. The aim of this trial was to prove or disprove investigated noninferiority of the novel device BiCision in comparison to the widely used UltraCision in a routine procedure (www.clinicaltrials.gov; study identifier NCT01806012). Methods: Thirty LASH procedures were performed with UltraCision and BiCision after randomization of the preparation sides. The primary end point was the resection time per side and instrument. The instruments were also compared concerning blood loss and coagulation and cutting qualities as well as postoperative complications. The patients were followed for 3 months. Results: Mean preparation time per side was 8.8 ± 1.8 min for BiCision and 8.3 ± 1.9 min for UltraCision (p = 0.31), which was not significantly different. Both instruments achieved complete transection without the need of additional cutting attempts. BiCision was significantly superior regarding the number of coagulations for complete hemostasis before and after the removal of the uterine corpus (before: 6.9 ± 4.8 for BiCision and 8.6 ± 4.1 for UltraCision, p = 0.047; after: 5.4 ± 1.2 for BiCision and 8.6 ± 3.2 for UltraCision, p < 0.0001) and intraoperative blood loss (score 1.07 ± 0.25 for BiCision vs. 1.63 ± 0.49 for UltraCision, p < 0.0001). Tissue sticking to the instrument occurred less often on the BiCision side (score 0.14 ± 0.35 for BiCision vs. 0.60 ± 0.81 for UltraCision, p = 0.015). BiCision showed a significantly better fixation of the tissue (grip score 0.23 ± 0.43 for BiCision vs. 1.00 ± 0.74 for UltraCision, p < 0.0001). No intraoperative or postoperative complications were seen for both instruments. Conclusions: The efficacy and quality of vessel sealing and cutting with BiCision is not inferior to the UltraCision device. Resection time was comparable, and complete hemostasis could be achieved faster in a clinical setting. Therefore, BiCision is at least as reliable as UltraCision for laparoscopic indications.