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

项目摘要 子宫阴道脱垂（UVP）是影响女性的最常见疾病之一，终生风险为20 UVP矫正手术为UVP进行的外科手术包括阴道或腹部入路， 或不使用网来矫正骨盆支撑的缺陷。有证据显示，对于... 子宫切除术盆腔器官脱垂（POP）修复，使用补片的患者结局上级 在不影响病人安全的情况下进行阴道修复然而，没有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治疗的最佳选择 手术：1）阴式子宫切除联合子宫骶韧带悬吊术（TVH+USLS）和2）最小 侵袭性子宫切除联合骶骨阴道固定术（MI-SCH+SCP）。 此外，手术决策是基于评估成功的客观指标的研究， 绝大多数开创性试验没有考虑到以患者为中心的结果， 手术，例如：休假、恢复正常活动、需要护理人员/支持人员和患者 对手术成功和生活质量改善的期望。为了填补这些知识 差距，TVH+USLS和MI-SCH+SCP之间的多机构比较研究将有三个具体的 目标。 首先，本研究将评价3年手术失败率，术后6个月评估MI， SCH+SCP与TVH+USLS相比;其中手术失败定义为存在至少一种 以下：1）存在阴道脱垂，定义为检查时脱垂超过处女膜，2） 报告令人烦恼的阴道隆起症状，无论脱垂阶段如何，或3）症状性复发的再治疗 子宫托脱垂或手术。其次，该研究将比较与围手术期护理相关的结局， 恢复，包括短期结局：术后疼痛、阿片类镇痛药使用、恶心、疲乏、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局 术后1个月即刻，此后间隔6个月。最后，研究将涉及 在术前、术后3个月和术后24个月对一组女性进行定性访谈 手术这些访谈的结果将与客观结果相结合， 以患者为中心的综合治疗盆腔器官脱垂的方法。

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.