以患者为中心的子宫阴道脱垂手术治疗结果 (PREMIER)
骶骨阴道固定术与子宫骶韧带悬吊术治疗子宫阴道脱垂的以患者为中心的结果
The purpose of this study is to compare two types of surgery for the treatment of uterovaginal prolapse to determine which surgery works best from a patient's perspective and has the lowest number of short-term and long-term complications.
研究概览
地位
条件
详细说明
This is a multi-site, randomized controlled trial, where women with the confirmed diagnosis of uterovaginal prolapse will be randomized in a 1:1 ratio to either A) a minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) or B) total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS). After surgery, participants will be followed for 3 years including physical pelvic exams and validated symptom questionnaires to assess for the primary and secondary outcomes. A subset of participants will participate in semi-structured interviews, before surgery and through 2 years after surgery, that will assess patient recovery, satisfaction with care, and calibrate surveyed and clinically assessed outcomes to the daily life experiences of women.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Florida
-
Jacksonville、Florida、美国、32224
- Mayo Clinic
-
-
Illinois
-
Chicago、Illinois、美国、60611
- Northwestern Medicine
-
-
North Carolina
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Durham、North Carolina、美国、27707
- Duke University
-
-
Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic
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Cleveland、Ohio、美国、44109
- MetroHealth Medical Center
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Cleveland、Ohio、美国、44106
- University Hospitals Cleveland Medical Center
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh, UPMC Magee-Womens Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Women ≥ 18 years of age and ≤ 80 years of age
- Have diagnosis of symptomatic uterovaginal prolapse
- Have elected to undergo surgical management of uterovaginal prolapse after consultation with their physician
- Are eligible for both minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) and total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
Exclusion Criteria:
- Patients who wish to undergo uterine sparing procedures
- Body mass index BMI) > 50
- Previous hysterectomy or prior uterovaginal surgery
- Have a diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular accident
- Chronic indwelling urinary catheter
- Urinary diversion of any type
- Any condition or disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
- Unable to speak, read, understand English
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Sacrocolpopexy
Minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) |
Minimally invasive robotic or laparoscopic supracervical hysterectomy will be done, and the vaginal apex (including cervix) will be suspended utilizing sacrocolpopexy mesh to the anterior spinous ligament. |
|
有源比较器：Uterosacral Ligament Suspension
Total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) |
The uterus will be removed vaginally and the vaginal apex will be suspended utilizing sutures in the uterosacral ligament. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Treatment failure
大体时间：36 months post-surgery
|
The primary outcome is treatment failure defined as the presence of at least one of the following: 1) presence of a vaginal bulge defined as lead point of prolapse beyond the hymen, 2) report of bothersome vaginal bulge symptoms irrespective of stage of prolapse, or 3) retreatment of symptomatic prolapse with pessary, or surgery. |
36 months post-surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative pain medication use
大体时间：Post-surgery through Day 14
|
Postoperative pain medication use will be assessed using the total morphine equivalent dosing (MED) for narcotics and using the total dosage for non-narcotics. |
Post-surgery through Day 14
|
|
Change in surgical pain using VAS
大体时间：Baseline, Days 1, 7 and 14 post-surgery
|
Longitudinal pain score will be assessed using a visual analog scale (VAS) with a score of 0 to 100 where a higher score means a worse outcome. |
Baseline, Days 1, 7 and 14 post-surgery
|
|
Postoperative anti-emetic use
大体时间：Post-surgery through Day 14
|
Postoperative anti-emetic use will be assessed using the total number of times patients take an anti-emetic. |
Post-surgery through Day 14
|
|
Change in nausea using VAS
大体时间：Baseline, Days 1, 7 and 14 post-surgery
|
Longitudinal nausea score will be assessed using a visual analog scale (VAS) with a score of 0 to 100 where a higher score means a worse outcome. |
Baseline, Days 1, 7 and 14 post-surgery
|
|
Change in fatigue using MAF
大体时间：Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, and 8 post-surgery
|
Fatigue will be assessed utilizing the Multi-Dimensional Assessment of Fatigue (MAF) Scale with a score of 1 to 148 where a higher score means a worse outcome. |
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, and 8 post-surgery
|
|
Change in bladder function using UDI-6
大体时间：Baseline, 2, 6, 12, 24, and 36 months post-surgery
|
Bladder function will be assessed using the Urinary Distress Inventory-6 (UDI-6) which is questions 15-20 of the Pelvic Floor Distress Inventory (PFDI-20) with a score of 0 to 18 where a higher score means a worse outcome. |
Baseline, 2, 6, 12, 24, and 36 months post-surgery
|
|
Change in bladder function using IIQ-7
大体时间：Baseline, 2, 6, 12, 24, and 36 months post-surgery
|
Bladder function will be assessed using the Incontinence Impact Questionnaire-7 (IIQ-7) with a score of 0 to 21 where a higher score means a worse outcome. |
Baseline, 2, 6, 12, 24, and 36 months post-surgery
|
|
Change in bowel function using CRAD-8
大体时间：Baseline, 2, 6, 12, 24, and 36 months post-surgery
|
Bowel function will be assessed using the Colorectal Anal Distress Inventory 8 (CRAD-8) which is questions 7-14 of the Pelvic Floor Distress Inventory (PFDI-20) with a score of 0 to 24 where a higher score means a worse outcome. |
Baseline, 2, 6, 12, 24, and 36 months post-surgery
|
|
Change in sexual function using PISQ-12
大体时间：Baseline, 6, 12, 24, and 36 months post-surgery
|
Sexual function will be assessed using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) with a score of 0 to 48 where a higher score means a worse outcome. |
Baseline, 6, 12, 24, and 36 months post-surgery
|
|
Change in sexual function using FSFI
大体时间：Baseline, 6, 12, 24, and 36 months post-surgery
|
Sexual function will be assessed using the Female Sexual Function Inventory (FSFI) with a score of 2 to 36 where higher score where a higher score means a better outcome. |
Baseline, 6, 12, 24, and 36 months post-surgery
|
|
Change in body image using BIPOP
大体时间：Baseline, 6, 12, 24, and 36 months post-surgery
|
Body image will be assessed using the Body Image in Pelvic Organ Prolapse Questionnaire (BIPOP) with a score of 1 to 5 where a higher score means a better outcome. |
Baseline, 6, 12, 24, and 36 months post-surgery
|
|
Change in quality of life using P-QOL
大体时间：Baseline, 2, 6, 12, 24, and 36 months post-surgery
|
General quality of life will be assessed using the Pelvic Organ Prolapse Quality of Life Questionnaire (P-QOL) with a score in each domain of 0 to 100 where a higher score means a worse outcome. |
Baseline, 2, 6, 12, 24, and 36 months post-surgery
|
|
Change in satisfaction with care using PGI-I
大体时间：Baseline, 6, 12, 24, and 36 months post-surgery
|
Satisfaction with care will be assessed using the Patient Global Impression of Improvement (PGI-I) scale with a score of 1 to 7 where higher score means a worse outcome. |
Baseline, 6, 12, 24, and 36 months post-surgery
|
|
Rate of Grade I-V DINDO complications in each surgical arm
大体时间：Surgery through 36 months post-surgery
|
Surgical complications will be assessed using the Clavien-Dindo standardized classification system with a grade of I to V where the higher grade means a worse outcome. |
Surgery through 36 months post-surgery
|
合作者和调查者
合作者
调查人员
- 首席研究员：Adonis Hijaz, MD、University Hospitals Cleveland Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 20210871
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
All of the individual participant data collected during the trial will be made available after de-identification.
IPD 共享时间框架
Beginning 9 months and ending 36 months following publication.
IPD 共享访问标准
Researchers who provide a methodologically sound proposal may use the data for any purpose.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
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研究美国 FDA 监管的设备产品
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