Laparoscopic inguinal ligament suspension versus laparoscopic sacrocolpopexy in the treatment of pelvic organ prolapse: study protocol for a randomized controlled trial.
Laparoscopic inguinal ligament suspension versus laparoscopic sacrocolpopexy in the treatment of pelvic organ prolapse: study protocol for a randomized controlled trial.
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腹腔镜腹股沟韧带悬吊术与腹腔镜骶骨阴道固定术治疗盆腔器官脱垂：随机对照试验的研究方案
DOI：
10.1186/s13063-018-2494-x
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发表时间：
2018-03-05
期刊：
影响因子：
2.5
通讯作者：
Shu H
中科院分区：
文献类型：
--
作者：
Li C;Dai Z;Shu H
盆腔器官脱垂(POP)是一种常见的健康问题。终生接受脱垂手术的风险为11%。POP对生活质量和日常生活能力的影响显著。对于希望接受重建手术的POP妇女，腹腔镜下的骶管固定术(LSC)已被视为治疗的黄金标准。然而，LSC存在技术上的困难，导致学习曲线和手术时间较长。最近，我们团队介绍了一种新的腹股沟韧带悬吊术(LILS)，并证实了其治疗阴道穹隆脱垂的安全性和有效性。作为治疗POP的一种新的手术技术，LILS与LSC标准技术的前瞻性随机对照试验是必要的。因此，我们将进行一项试验。方法试验为随机对照试验。它比较了LILS和LSC在2期或更高程度的子宫脱垂的妇女中的作用。这项研究的主要结果是围术期参数，包括手术时间、出血量、术中并发症和住院时间，以及在术后6周、6个月、12个月和每年直到5年的盆腔器官脱垂问卷(POP-Q)分级的手术解剖结果。次要结果是泌尿生殖系统症状和生活质量的主观改善、术后并发症、术后恢复、性功能和每个随访点的成本效益。将使用经过验证的问卷，并根据意向治疗原则对数据进行分析。基于90%的客观成功率，15%的非劣势边缘，20%的失败率，每支手臂需要107名患者来证明这一假设，可信区间为95%。讨论本试验是一项随机对照的多中心非劣势试验，将为LILS在有症状的2期或更高的子宫脱垂的妇女中的有效性和安全性提供证据。注册日期为2015年11月9日。
BackgroundPelvic organ prolapse (POP) is a common health problem. The lifetime risk of undergoing surgery for prolapse is 11%. POP significantly affects the effects on quality of life and activities of daily living. Laparoscopic sacrocolpopexy (LSC) has been viewed as the gold standard treatment for women with POP who desire reconstructive surgery. However, LSC is associated with technical difficulties, resulting in a long learning curve and operative time. Recently, our team introduced a new laparoscopic technique of inguinal ligament suspension (LILS) and had confirmed its safety and efficacy in treating vaginal vault prolapse. As a new surgical technique for POP, a prospective randomized controlled trial comparing the LILS with the standard technique of LSC is necessary. Therefore, we will conduct a trial.MethodsThe trial is a randomized controlled trial. It compares LILS with LSC in women with stage 2 or higher uterine prolapse. The primary outcomes of this study are perioperative parameters, including surgical time, blood loss, intraoperative complications, and hospital stay as well as surgical anatomical results using the pelvic organ prolapse questionnaire (POP-Q) classification at 6 weeks, 6 months, 12 months, and annually till 5 years after surgery. Secondary outcomes are subjective improvement in urogenital symptoms and quality of life, postoperative complications, postoperative recovery, sexual functioning, and cost-effectiveness at each follow-up point. Validated questionnaires will be used and the data will be analyzed according to the intention-to-treat principle. Based on an objective success rate of 90%, a noninferiority margin of 15%, and a dropout of 20%, 107 patients are needed in each arm to prove the hypothesis with a 95% confidence interval.DiscussionThe trial is a randomized controlled, multicenter, noninferiority trial that will provide evidence whether the efficacy and safety of LILS is noninferior to LSC in women with symptomatic stage 2 or higher uterine prolapse.Trial registrationChina Trial Register (CTR): ChiCTR-INR-15007408 . Registered on 9 November 2015.
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