Patient-Centered Outcomes of Sacrocolpopexy versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse

项目总结 子宫阴道脱垂(UVP)是影响女性的最常见疾病之一，有20%的终生风险 UVP矫正手术。治疗UVP的手术包括经阴道或腹部手术， 或不使用网片，以纠正骨盆支持的缺陷。积累的证据表明，对于邮政- 子宫切除术后盆腔脏器脱垂(POP)修补术与使用网片的疗效比较 在不危及患者安全的情况下进行阴道修复。然而，并不存在高质量的数据来帮助指导 患者和外科医生对两种最常见的UVP的最佳治疗方案 手术方式：1)阴式全子宫切除+子宫-骶韧带悬吊术(TVH+USLS)；2)微创子宫切除术 侵袭性全子宫切除联合固定术(MI-SCH+SCP)。 此外，手术决策是基于评估成功的客观衡量标准的研究， 绝大多数开创性试验没有考虑到以患者为中心的结果与选择一种 手术：休假、恢复正常活动、需要照顾者/支持人员和病人 对手术成功和生活质量改善的期望。为了填补这方面的知识 GAP，这项TVH+USLS和MI-SCH+SCP的多机构比较研究将有三个具体的 目标。 首先，这项研究将评估3年手术失败率，每隔6个月评估一次心肌梗塞。 SCH+SCP与TVH+USLS的比较；其中手术失败定义为存在至少一种 以下：1)阴道脱垂在检查中被定义为超过处女膜脱垂的前导点，2) 报告与脱垂阶段无关的烦人的阴道隆起症状，或3)有症状的再次治疗 用剖腹产或手术脱垂。其次，这项研究将比较围手术期护理和 恢复，包括短期结果：术后疼痛、阿片类止痛药使用、恶心、疲劳、手术 评估与身体形象、性、肠道和膀胱功能相关的发病率和长期结果 术后即刻1个月，此后每隔6个月一次。最后，研究将涉及 在手术前、术后3个月和24个月对一组女性进行定性访谈 做手术。这些访谈的结果将与客观结果结合起来，以制定一项 以患者为中心的综合治疗方法治疗盆腔器官脱垂。

PROJECT SUMMARY Uterovaginal prolapse (UVP) is one of the most common conditions affecting women, with a 20% lifetime risk of UVP corrective surgery. Surgeries performed for UVP include either a vaginal or abdominal approach, with or without use of mesh, to correct defects in pelvic support. Accumulated evidence has shown that for post- hysterectomy pelvic organ prolapse (POP) repair, the use of mesh yields superior patient outcomes compared to vaginal repair without compromising patient safety. However, no high-quality data exists to help guide patients and surgeons on the best option for treatment of UVP of the two most commonly performed procedures: 1) vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) and 2) minimally invasive hysterectomy with sacrocolpopexy (MI-SCH+SCP). Furthermore, surgical decision making is based on studies which evaluate objective measures of success, with the vast majority of seminal trials not taking into account patient-centered outcomes related to choosing a surgery such as: time off work, return to normal activity, need for caregivers/support persons and patient expectations for what constitutes successful surgery and improvement in quality of life. To fill this knowledge gap, this multi-institutional comparative study between TVH+USLS and MI-SCH+SCP will have three specific aims. First, the study will evaluate 3-year surgical failure rates, assessed at 6-month intervals postoperatively for MI- SCH+SCP compared to TVH+USLS; where surgical failure is defined as presence of at least one of the following: 1) presence of vaginal prolapse defined as a lead point of prolapse beyond the hymen on exam, 2) report of bothersome vaginal bulge symptoms irrespective of prolapse stage, or 3) retreatment of symptomatic prolapse with pessary, or surgery. Second, the study will compare outcomes related to perioperative care and recovery including short-term outcomes: post-operative pain, opioid analgesia use, nausea, fatigue, surgical morbidity and long-term outcomes related to body image, sexual, bowel and bladder function assessed immediate postoperatively at 1 month, and at 6 month intervals thereafter. Finally, the study will involve qualitative interviews of a sub-set of women conducted prior to surgery, and at 3 months and 24 months after surgery. The results of these interviews will be incorporated with objective outcomes to develop a comprehensive, patient-centered approach to the treatment of pelvic organ prolapse.