A Prospective Randomized Trial Comparing Restorelle Y Mesh vs. Restorelle Dual Flat Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Total OR Time = Operating Room Time of Entry and Exit
研究概览
简要总结
The primary objective of the proposed study is to determine the difference in suturing time when using the restorelle Y mesh versus the restorelle dual flat mesh at the time of laparoscopic and robotic-assisted laparoscopic sacrocolpopexy.
Hypothesis: Suturing time when using the restorelle Y mesh will be faster than when using the restorelle dual flat mesh at the time of laparoscopic and robotic-assisted laparoscopic sacrocolpopexy.
详细描述
Study Design: Randomized single-blind prospective clinical trial
Primary Outcomes:
- Total Suturing time for mesh placement = time from insertion of Y mesh or first flat mesh arm into pelvis to last sacral suture placed
- Total Case time = Incision to end of closure
Secondary Outcomes:
Post-operative patient outcomes at 24-months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18, who are to undergo laparoscopic or robotic laparoscopic sacrocolpopexy for pelvic organ prolapse
- •Other concomitant laparoscopic or prolapse and anti-incontinence procedures (e.g., laparoscopic supracervical hysterectomy, cystocele repair, rectocele repair or mid-urethral sling procedures) will be performed at the primary surgeon's discretion.
排除标准
- •Inability to comprehend written and/or spoken English
- •Inability to provide informed consent
- •Medical illness precluding laparoscopy
- •Need for concomitant surgeries not related to pelvic organ prolapse or incontinence
- •Sacrocolpoperineopexy
研究组 & 干预措施
Coloplast, Inc. Restorelle Dual flat mesh
Dual flat mesh
干预措施: Dual flat mesh (Device)
Cololast, Inc. Restorell Y mesh
Y mesh
干预措施: Y mesh (Device)
结局指标
主要结局
Total OR Time = Operating Room Time of Entry and Exit
时间窗: one day intraoperative
Total Suturing Time for Mesh Placement = Time From Insertion of Y Mesh or First Flat Mesh Arm Into Pelvis to Last Sacral Suture Placed
时间窗: one day intraoperative
次要结局
- Post-operative Mean Difference POPDI at 24 Months(24 months)
- Postoperative Mean Difference CRADI at 24 Months(24 months)
- Postoperative Mean Difference UDI at 24 Months(24 months)
- Postoperative Subjective Recurrence at 24 Months(24 months)
- Postoperative Objective Recurrence at 24 Months(24 months)
- Reported Mesh Erosion at 24 Months(24 months)