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: 10279888
• 负责人: Adonis K Hijaz
• 金额: $ 69.2万
• 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/10279888
• 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.

项目摘要 子宫阴道脱垂（UVP）是影响女性的最常见疾病之一，终身风险为20％ UVP矫正手术。为UVP进行的手术包括阴道或腹部手术， 或不使用网格，以纠正骨盆支撑中的缺陷。积累的证据表明，在 子宫切除术骨盆器官脱垂（POP）修复，使用网格可获得卓越的患者预后 进行阴道修复，而不会损害患者的安全。但是，不存在高质量数据来指导 患者和外科医生是对两个最常见的UVP治疗的最佳选择 程序：1）带子宫韧带悬浮液（TVH+USL）和2）最小的阴道子宫切除术（TVH+USL） 侵入性子宫切除术，带sapococolocopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopopope。 此外，手术决策是基于评估成功措施的研究 绝大多数的开创性试验未考虑与选择相关的以患者为中心的结果 手术，例如：休假时间，恢复正常活动，需要照顾者/支持人员和患者 对构成成功手术和生活质量改善的期望。填写这一知识 差距，TVH+USLS和Mi-SCH+SCP之间的多机构比较研究将具有三个特定的特定 目标。 首先，该研究将评估3年的手术衰竭率，并在术后6个月进行评估 与TVH+USL相比，SCH+SCP；如果手术衰竭定义为至少存在 以下：1）存在于检查中处女膜以外的脱垂的阴道脱垂的存在，2） 不论脱垂阶段不论造成的阴道隆起症状的报道，或3）有症状的恢复 子宫或手术脱垂。其次，该研究将比较与围手术期护理有关的结果和 恢复包括短期结局：术后疼痛，阿片类镇痛使用，恶心，疲劳，手术 评估了与身体形象，性，肠和膀胱功能有关的发病率和长期结局 术后立即在1个月内，此后6个月间隔。最后，研究将涉及 对手术前进行的一组女性的定性访谈，以及3个月和24个月后 外科手术。这些访谈的结果将与客观成果合并，以开发 全面，以患者为中心的方法来治疗骨盆器官脱垂。