Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Subjective and Objective Outcomes With Learning Curves in the Development of a New Pelvic Floor Robotics Program
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Learning curve of robotic sacral colpopexy
研究概览
简要总结
The investigators scientific aims are to determine the benefits associated with the use of robotic assisted laparoscopic sacrocolpopexy surgery on women with prolapse, to define how the benefits impact the patient, physician and the institution, and to determine the complications associated with the use of the robot. This will be a prospective cohort following 100 patients for a 24 month period.
详细描述
The investigators scientific aims are to determine the benefits associated with the use of robotic assisted laparoscopic sacrocolpopexy surgery on women with prolapse, to define how the benefits impact the patient, physician and the institution, and to determine the complications associated with the use of the robot. This will be a prospective cohort following 100 patients for a 24 month period.
The investigators primary outcomes will be:
- Surgical time: Key portion of procedure will be assessed along with total time for completion
- Learning curve: Will be assessed using surgical times, VAS of camera skills, surgical skills involving tissue handling and movements and overall performance by surgeon, assistant and blind reviewer
- Length of hospitalization: measured by days in hopsital
The investigators secondary outcomes will be:
- Pre-operative and postoperative Pelvic Organ Prolapse-Quantification (POP-Q) at 6 week, 6, 12, and 24 months.
- Pelvic Floor Distress Inventory-Short Form 20 Questionnaire (PFDI-20)
- Mesh erosion,
- Estimated blood loss,
- Complications (bowel or bladder injury) and,
- Wound infection,
- Patient Global Impressions of Improvement
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •> 18 years old
- •Females only
- •Undergoing robotic assisted laparoscopic sacrocolpopexy with or without other procedures for pelvic organ prolapse
- •Willing to return for follow-up visits
- •Written informed consent obtained from each subject
排除标准
- •Decline to participate
- •Pregnant or contemplating future pregnancy (within a year)
- •Unable to participate in the informed consent process
结局指标
主要结局
Learning curve of robotic sacral colpopexy
时间窗: 24 months
To assess learning curve during implementation of a new pelvic floor robotic program which will assess surgical time (total and specific essential portions), simulator training and surgeon, observational surgeon skills by surgeon, assistant and blinded assessor
次要结局
- Objective outcomes measures associated with robotic sacral colpopexy(24 months)
- Subjective outcomes for robotic sacral colpopexy(Two years)
- Adverse events for robotic sacral colpopexy(Two years)
研究者
Shawn A Menefee, MD
Principal Investigator
Kaiser Permanente