Laparoscopic 3D Versus 2D Sacral Colpopexy and Paravaginal Repair for Pelvic Organ Prolapse: a Comparison of Operative Times and Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 4
- 主要终点
- Operative Times
研究概览
简要总结
Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.
详细描述
The purpose of this study is to compare operative times of laparoscopic sacral colpopexy (LSC) for the treatment of symptomatic vaginal vault prolapse as well as paravaginal repair (PVR) for symptomatic cystocele between two-dimensional and three-dimensional laparoscopic systems. Additionally this study will evaluate postoperative complications from surgeries performed using two-dimensional versus three-dimensional laparoscopic systems.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Symptomatic vaginal vault prolapse (stage 2 or greater point C-1 pelvic organ prolapse quantification [POP-Q] or grade 2 or greater Baden-Walker half way system) undergoing laparoscopic sacral colpopexy
- •Symptomatic cystocele (stage 2 or greater, point Aa or Ba > -1 POP-Q or grade 2 or greater Baden-Walker half way system) undergoing laparoscopic paravaginal repair
排除标准
- •Age less than 18 years
- •Inability to comprehend questionnaires
- •Inability to give informed consent or to return for review
- •Vaginal vault prolapse < stage 2
- •Unable to undergo general anesthesia
- •More than 5 previous laparotomies
- •Prior sacral colpopexy or vaginal mesh prolapse procedure
- •Prior surgery involving the retropubic space
- •Vaginal length less than 6 cm
研究组 & 干预措施
2D mode LSC
2D mode of the 3D Laparoscopic Video System for the Laprascopic Sacral Colpopexy (LSC) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
干预措施: 2D mode of the 3D Laparoscopic Video System (Device)
3D mode LSC
3D mode of the 3D Laparoscopic Video System for the Laprascopic Sacral Colpopexy (LSC) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
干预措施: 3D mode of the 3D Laparoscopic Video System (Device)
2D mode PVR
2D mode of the 3D Laparoscopic Video System for the Paravaginal Repair (PVR) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
干预措施: 2D mode of the 3D Laparoscopic Video System (Device)
3D mode PVR
3D mode of the 3D Laparoscopic Video System for the Paravaginal Repair (PVR) arm. Use of the 3D laparoscopic system can be switched to either 2D or 3D.
干预措施: 3D mode of the 3D Laparoscopic Video System (Device)
结局指标
主要结局
Operative Times
时间窗: Intraoperative
Operative times of laparoscopic sacral colpopexy and paravaginal repair procedures from the first part of dissection until closure of the peritoneum.
次要结局
- Complications(Intraoperative up to 6 weeks post procedure)