Sesti F, Capobianco F, Capozzolo T, Pietropolli A, Piccione E
Section of Gynecology and Obstetrics, Department of Surgery, School of Medicine, Tor Vergata Hospital University of Rome, Viale Oxford 81, 00133, Rome, Italy.
Surg Endosc. 2008 Apr;22(4):917-23. doi: 10.1007/s00464-007-9516-1. Epub 2007 Aug 20.
Isobaric gasless laparoscopy and minilaparotomy have been used as more recent minimally invasive approaches to myomectomy. This randomized trial aimed to compare the surgical and immediate postoperative outcomes for myomectomy performed by isobaric gasless laparoscopy with those for minilaparotomy.
A total of 100 patients with symptomatic uterine myomas requiring myomectomy were randomly allocated to the gasless laparoscopy group or the minilaparotomy group. The randomization procedure was based on a computer-generated list. The primary outcome was a comparison of the discharge times between the two procedures. A power calculation verified that more than 26 patients for each group was necessary to detect a difference of more than 24 h in discharge time with an alpha error level of 5% and a beta error of 80%. Continuous outcome variables were analyzed using the Student's t-test. Discrete variables were analyzed with the chi-square test or Fisher's exact test. A p value less than 0.05 was considered statistically significant.
The mean discharge time was longer for minilaparotomy than for gasless laparoscopy (98.4 +/- 1.4 vs 52.8 +/- 1.6 h; p < 0.001). Gasless laparoscopy resulted in shorter times for canalization (21.6 +/- 1.1 vs 32 +/- 1.3 h; p < 0.05) and surgery (79.5 +/- 25.1 vs 103.5 +/- 24.9 min; p < 0.001). The intraoperative blood loss was less with gasless laparoscopy (154.2 +/- 1.2 vs 188.6 +/- 1.3 ml; p < 0.001). No intraoperative complications occurred, and no case was returned to the theater in either group. No conversion to standard laparotomy was necessary.
Isobaric gasless laparoscopy and minilaparotomy can be suitable options for uterine myomectomy. Several surgical and immediate postoperative outcomes were significantly better in the gasless laparoscopy group than in the minilaparotomy group. However, further controlled prospective studies are required to confirm the results.
等压无气腹腔镜手术和小切口剖腹术已成为子宫肌瘤切除术的最新微创方法。这项随机试验旨在比较等压无气腹腔镜子宫肌瘤切除术与小切口剖腹术的手术及术后即刻效果。
总共100例有症状且需要进行子宫肌瘤切除术的患者被随机分配至无气腹腔镜组或小切口剖腹术组。随机化程序基于计算机生成的列表。主要结局是比较两种手术方式的出院时间。功效分析证实，每组需要超过26例患者才能在α错误水平为5%、β错误为80%的情况下检测出出院时间差异超过24小时。连续结局变量采用Student's t检验进行分析。离散变量采用卡方检验或Fisher精确检验进行分析。p值小于0.05被认为具有统计学意义。
小切口剖腹术的平均出院时间比无气腹腔镜手术长（98.4±1.4 vs 52.8±1.6小时；p<0.001）。无气腹腔镜手术的通管时间（21.6±1.1 vs 32±1.3小时；p<0.05）和手术时间（79.5±25.1 vs 103.5±24.9分钟；p<0.001）更短。无气腹腔镜手术的术中失血量更少（154.2±1.2 vs 188.6±1.3毫升；p<0.001）。两组均未发生术中并发症，也没有病例返回手术室。无需转为标准剖腹术。
等压无气腹腔镜手术和小切口剖腹术都是子宫肌瘤切除术的合适选择。无气腹腔镜组的一些手术及术后即刻效果明显优于小切口剖腹术组。然而，需要进一步的对照前瞻性研究来证实这些结果。
