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.

项目总结