Randomized controlled trial comparing operative times between standard and robot-assisted laparoscopic hysterectomy.
Randomized controlled trial comparing operative times between standard and robot-assisted laparoscopic hysterectomy.
复制标题
比较标准腹腔镜子宫切除术和机器人辅助腹腔镜子宫切除术的手术时间的随机对照试验。
DOI：
10.1002/ijgo.12001
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发表时间：
2017-01
期刊：
影响因子：
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通讯作者：
Harkins GJ
中科院分区：
文献类型：
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作者：
Deimling TA;Eldridge JL;Riley KA;Kunselman AR;Harkins GJ
比较机器人辅助腹腔镜直肠癌切除术和标准腹腔镜直肠癌切除术的手术时间。一项前瞻性随机对照试验招募了2014年4月23日至10月20日期间在宾夕法尼亚州立好时医疗中心接受子宫切除术的18-80岁女性。参与者使用随机数字发生器随机接受机器人辅助或标准腹腔镜子宫切除术。主要结局是总手术时间（外科医生切口至外科医生停止，包括机器人对接时间，如适用）。进行了意向治疗分析，并比较了两种治疗之间的手术时间的非劣效性，定义为手术时间差异不超过15分钟。每个治疗组随机分配72例患者，机器人辅助子宫切除术组的平均手术时间为73.9分钟（中位数67.0分钟;四分位数范围59.0-83.0分钟），标准腹腔镜子宫切除术组为74.9分钟（中位数65.5分钟;四分位数范围57.0-90.5分钟）。手术时间差异的95%置信区间上限为6.6分钟，低于15分钟的非劣效性指标。当由两种技术经验丰富的外科医生执行时，机器人辅助腹腔镜子宫切除术的手术时间不劣于标准腹腔镜子宫切除术。机器人辅助腹腔镜子宫切除术的手术时间不劣于标准腹腔镜子宫切除术。
To compare the operative time between robot-assisted laparoscopic hysterectomies and standard laparoscopic hysterectomies. A prospective, randomized controlled trial enrolled women aged 18–80 years attending Penn State Hershey Medical Center between April 23 and October 20, 2014 to undergo hysterectomy. Participants were randomized using a random number generator to undergo either robot-assisted or standard laparoscopic hysterectomy. The primary outcome was the total operative time (surgeon incision to surgeon stop, including robot docking time, if applicable). Intention-to-treat analyses were performed and the operative time was compared between the two treatments for non-inferiority, defined as a difference in operative time of no longer than 15 minutes. There were 72 patients randomized to each treatment arm. The mean operative time was 73.9 minutes (median 67.0 minutes; interquartile range 59.0–83.0 minutes) in the robot-assisted hysterectomy group and 74.9 minutes (median 65.5 minutes; interquartile range 57.0–90.5 minutes) in the standard laparoscopic hysterectomy group. The upper bound of the 95% confidence interval of the difference in operative time was 6.6 minutes, below the 15-minute measure of non-inferiority. When performed by a surgeon experienced in both techniques, the operative time for robot-assisted laparoscopic hysterectomy was non-inferior to that achieved with standard laparoscopic hysterectomy. The operative time of robot-assisted laparoscopic hysterectomy was non-inferior to that of standard laparoscopic hysterectomy.