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
- 2
- 主要终点
- Total Suturing Time for Mesh Placement = Time From Insertion of Y Mesh or First Flat Mesh Arm Into Pelvis to Last Sacral Suture Placed
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
结局指标
主要结局
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
Total OR Time = Operating Room Time of Entry and Exit
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)