Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen, Germany.
J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):661-6. doi: 10.1016/j.jmig.2013.04.014. Epub 2013 Jun 20.
To compare the EnSeal device with standard bipolar coagulation forceps in laparoscopic supracervical hysterectomy (LASH).
Prospective, randomized, controlled trial (Canadian Task Force classification I).
University hospital.
One hundred sixty patients who underwent LASH.
Eighty patients underwent LASH using the EnSeal device (experimental group), and 80 patients underwent LASH using standard bipolar coagulation forceps (control group) (www.clinicaltrials.gov; study identifier NCT01806012).
Mean (SD) total operative time was 78.18 (33.96) minutes in the experimental group and 86.30 (35.34) minutes in the control group (p = .03). Documented blood loss was <50 mL in 72 patients in the experimental group and 62 patients in the control group (p = .03), and was 50 to 100 mL in 8 patients in the experimental group and 18 patients in the control group (p < .001). Postoperative hospital stay was significantly shorter for patients in the experimental group compared with the control group: 2.01 (0.44) days vs 2.17 (0.47) days, respectively (p = .03). There was no difference in postoperative pain scores and complications between the two treatment groups.
Total resection time was shorter in the experimental group, and the other investigated clinical parameters were not inferior in the experimental group compared with the control group. The results of the present study indicate that use of the EnSeal device is at least as reliable as the conventional electrocoagulation technique in LASH.
比较 EnSeal 装置与标准双极电凝镊在腹腔镜子宫次全切除术（LASH）中的应用。
前瞻性、随机、对照试验（加拿大卫生研究院临床试验分级 I 类）。
大学医院。
160 例行 LASH 的患者。
80 例行 EnSeal 装置（实验组）LASH 的患者，80 例行标准双极电凝镊（对照组）LASH 的患者（www.clinicaltrials.gov；研究标识符 NCT01806012）。
实验组的平均（标准差）总手术时间为 78.18（33.96）分钟，对照组为 86.30（35.34）分钟（p =.03）。实验组有 72 例患者术中出血量<50 mL，62 例患者术中出血量为 50100 mL；对照组有 62 例患者术中出血量<50 mL，18 例患者术中出血量为 50100 mL（p =.03）。实验组患者术后住院时间明显短于对照组：分别为 2.01（0.44）天和 2.17（0.47）天（p =.03）。两组患者术后疼痛评分和并发症发生率无差异。
实验组的总切除时间更短，且实验组的其他研究参数与对照组相比不劣。本研究结果表明，在 LASH 中，EnSeal 装置的使用至少与传统电凝技术一样可靠。
