Li Chunbo, Dai Zhiyuan, Shu Huimin
Department of Gynaecology and Obstetrics, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, 536 Changle Road, Shanghai, China.
Trials. 2018 Mar 5;19(1):160. doi: 10.1186/s13063-018-2494-x.
Pelvic 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.
The 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.
The 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.
China Trial Register (CTR): ChiCTR-INR-15007408 . Registered on 9 November 2015.
盆腔器官脱垂（POP）是一个常见的健康问题。因脱垂接受手术的终生风险为11%。POP对生活质量和日常生活活动有显著影响。腹腔镜骶骨阴道固定术（LSC）被视为希望接受重建手术的POP女性的金标准治疗方法。然而，LSC存在技术难题，导致学习曲线长和手术时间长。最近，我们团队引入了一种新的腹腔镜腹股沟韧带悬吊术（LILS），并已证实其治疗阴道穹窿脱垂的安全性和有效性。作为一种新的POP手术技术，有必要进行一项前瞻性随机对照试验，将LILS与LSC的标准技术进行比较。因此，我们将开展一项试验。
该试验为随机对照试验。在2期或更高程度子宫脱垂的女性中比较LILS与LSC。本研究的主要结局是围手术期参数，包括手术时间、失血量、术中并发症、住院时间，以及术后6周、6个月、12个月以及术后直至5年每年使用盆腔器官脱垂问卷（POP-Q）分类评估的手术解剖学结果。次要结局是各随访点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、性功能以及成本效益。将使用经过验证的问卷，并根据意向性分析原则对数据进行分析。基于90%的客观成功率、15%的非劣效性界值和20%的失访率，每组需要107例患者以95%的置信区间证明假设。
该试验是一项随机对照、多中心、非劣效性试验，将提供证据证明LILS在有症状的2期或更高程度子宫脱垂女性中的疗效和安全性是否不劣于LSC。
中国临床试验注册中心（CTR）：ChiCTR-INR-15007408。于2015年11月9日注册。
