Robotic-assisted Laparoscopic Sacrocolpopexy: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary outcomes are operative time, blood loss, complication rates, length of hospital stay, and cure. Objective cure can be measured using the pelvic organ prolapse quantification exam (POP-Q).
研究概览
简要总结
Robotic-assisted Abdominal Sacrocolpopexy is both a feasible and safe method for apical prolapse repair of the vagina.
详细描述
Robotics offers many advantages over traditional laparoscopy: 1) intuitive movement of instruments, 2) "wristed instruments" with increased degrees of freedom, 3) enhanced 12X magnification, 4) 3-D depth perception, 5)tremor filtration, 6) enhanced surgeon comfort and ergonomics, and 7) a steeper learning curve. With robotic assistance, the surgeon can comfortably perform precise, repetitive motions, with greater dexterity and vision. To date, there have been a small number of published cases of laparoscopic sacrocolpopexy and two cases of series utilizing robotic-assistance. There have been no prospective, randomized, controlled trials comparing either of these modalities to conventional abdominal sacrocolpopexy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Non-pregnant women
- •Age >18 years
- •Eligible for sacrocolpopexy
- •Prior hysterectomy
- •Stage II or greater post hysterectomy vault prolapse
- •Satisfied parity
- •Patients electing for an abdominal repair to posthysterectomy vault prolapse
排除标准
- •Prisoners
- •Cognitively impaired adults
- •Not medically stable to undergo laparoscopic or abdominal surgery
- •Previous pelvic/vaginal radiation
- •Participants electing to proceed with a vaginal repair of vaginal vault prolapse
- •Participants electing to proceed with the traditional abdominal sacrocolpopexy
- •History of recurrent vaginal infections
- •Known urologic and/or gynecologic cancer
结局指标
主要结局
The primary outcomes are operative time, blood loss, complication rates, length of hospital stay, and cure. Objective cure can be measured using the pelvic organ prolapse quantification exam (POP-Q).
时间窗: 2 years
time, estimated blood loss, UTI, duration-of stay
次要结局
- Secondary outcomes will measure the effects of the surgical repair using a series of questionnaires: SF-36, Pelvic Floor Distress Inventory which includes Pelvic Organ Prolapse Impact, Colo-Rectal-Anal Impact, and Urinary Impact Questionnaire.(2 Years)
研究者
Felicia Lane
Professor and Vice Chair of Obstetrics & Gynecology
University of California, Irvine