Department of Obstetrics and Gynecology, University of Tuebingen, Calwerstr. 7, 72076, Tuebingen, Germany.
Surg Endosc. 2013 Oct;27(10):3852-9. doi: 10.1007/s00464-013-2994-4. Epub 2013 May 14.
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).
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.
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.
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.
子宫切除术有多种手术方式；近年来，腹腔镜子宫次全切除术（LASH）已成为一种成熟的选择。因此，用于快速组织密封和切割的能量技术是外科医生关注的焦点。本试验旨在证明或反驳新型 BiCision 装置与广泛使用的 UltraCision 在常规手术中的非劣效性（www.clinicaltrials.gov；研究标识符 NCT01806012）。
在准备侧随机分组后，进行 30 例 LASH 手术。主要终点是每侧和器械的切除时间。还比较了器械的出血量、凝血和切割质量以及术后并发症。对患者进行了 3 个月的随访。
BiCision 每侧的平均准备时间为 8.8±1.8 分钟，UltraCision 为 8.3±1.9 分钟（p=0.31），差异无统计学意义。两种器械均能实现完全横断，无需额外的切割尝试。BiCision 在子宫体切除前后完全止血所需的凝血次数明显优于 UltraCision（前：BiCision 为 6.9±4.8，UltraCision 为 8.6±4.1，p=0.047；后：BiCision 为 5.4±1.2，UltraCision 为 8.6±3.2，p<0.0001）和术中出血量（BiCision 评分为 1.07±0.25，UltraCision 评分为 1.63±0.49，p<0.0001）。BiCision 侧组织粘在器械上的情况较少（BiCision 评分为 0.14±0.35，UltraCision 评分为 0.60±0.81，p=0.015）。BiCision 对组织的固定明显更好（BiCision 的夹持评分 0.23±0.43，UltraCision 的夹持评分 1.00±0.74，p<0.0001）。两种器械均未出现术中或术后并发症。
BiCision 血管密封和切割的效果和质量不劣于 UltraCision 装置。切除时间相当，在临床环境下更快地达到完全止血。因此，BiCision 用于腹腔镜手术与 UltraCision 一样可靠。
