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

以患者为中心的骶阴道固定术与子宫骶韧带悬吊术治疗子宫阴道脱垂的结果

• 批准号: 10472722
• 负责人: Adonis K Hijaz
• 金额: $ 65.24万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-20 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10472722
• 关键词: Abdomen; Accounting; Address; Affect; Aftercare; American; Americas; Apical; Atopobium vaginae; Bladder; Body Image; Caregiver support; Caring; Clinical Trials Design; Comparative Study; Data; Decision Making; Defect; Diagnosis; Effectiveness; Failure; Fatigue; Goals; Hysterectomy; Intervention; Interview; Intestines; Knowledge; Lead; Ligaments; Light; Literature; Litigation; Measures; Methods; Modality; Morbidity - disease rate; Nausea; Observational Study; Operative Surgical Procedures; Opioid Analgesics; Outcome; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Pelvic Floor Disorders; Pelvis; Perception; Perioperative; Perioperative Care; Persons; Pessaries; Postoperative Complications; Postoperative Pain; Postoperative Period; Probability; Procedures; Professional Organizations; Ptosis; Qualitative Research; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Recovery; Reporting; Research; Research Methodology; Retreatment; Selection for Treatments; Seminal; Series; Severities; Sex Functioning; Societies; Surgeon; Surgical Specialties; Suspensions; Symptoms; Time; United States; Vagina; Vaginal Hysterectomy; Vaginal Prolapses; Voice; Woman; Work; base; comparative; effectiveness evaluation; expectation; experience; hymen; individual patient; lifetime risk; minimally invasive; pain score; patient expectation; patient oriented; patient safety; pelvic organ prolapse; personalized approach; postoperative recovery; preference; repaired; shared decision making; social stigma; success; surgery outcome; surgical research; tissue repair; trial comparing; trial design

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.

项目概要 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。 UVP 的手术包括阴道或腹部手术， 或不使用网片，以纠正骨盆支撑的缺陷。积累的证据表明，对于后期 子宫切除术、盆腔器官脱垂 (POP) 修复术中，使用网片可带来更好的患者治疗效果 在不影响患者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 患者和外科医生讨论两种最常进行的 UVP 治疗的最佳选择 手术：1) 阴道子宫切除术，子宫骶韧带悬吊术 (TVH+USLS) 和 2) 最低限度 侵入性子宫切除术联合骶骨阴道固定术 (MI-SCH+SCP)。 此外，手术决策是基于评估客观成功衡量标准的研究， 绝大多数开创性试验没有考虑到与选择治疗相关的以患者为中心的结果 手术，例如：请假、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。来填补这些知识 为了解决这个差距，TVH+USLS 和 MI-SCH+SCP 之间的多机构比较研究将有三个具体内容 目标。 首先，该研究将评估 3 年手术失败率，术后每隔 6 个月评估一次 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，定义为检查时脱垂的主导点超出处女膜，2) 报告有令人烦恼的阴道膨出症状，无论脱垂阶段如何，或 3) 重新治疗有症状的 子宫托脱垂，或手术。其次，该研究将比较围手术期护理和 康复，包括短期结果：术后疼痛、阿片类镇痛剂的使用、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 1 个月立即进行一次，此后每隔 6 个月进行一次。最后，研究将涉及 对一部分女性在手术前、手术后 3 个月和 24 个月进行定性访谈 外科手术。这些访谈的结果将与客观结果结合起来，以制定 以患者为中心的综合方法治疗盆腔器官脱垂。