Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Pelvic Organ Prolapse - Quantification Point C
研究概览
简要总结
The purpose of this study is to learn about the effect of different vaginal cuff closure techniques on pelvic support after laparoscopic hysterectomy and robotic assisted laparoscopic hysterectomy for benign gynecologic conditions.
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
- Double (Participant, Outcomes Assessor)
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
- •Women over 18 years of age undergoing total laparoscopic hysterectomy and robotic assisted total laparoscopic hysterectomy for benign disease.
- •Subjects must be able to self-consent.
- •Department of Defense beneficiary
排除标准
- •Patients will be excluded if they undergo a concurrent procedure for prolapse.
- •If the indication for the procedure is a malignancy.
- •Those that plan to leave the area in less than 1 year will not be included.
- •Pop-Q Point C of >-4
研究组 & 干预措施
Laparoscopic - Vaginal Cuff Closure
干预措施: Laparoscopic - Vaginal Cuff Closure (Procedure)
Vaginal - Vaginal Cuff Closure
干预措施: Vaginal- Vaginal Cuff Closure (Procedure)
结局指标
主要结局
Pelvic Organ Prolapse - Quantification Point C
时间窗: 1 year post op
The Pelvic Organ Prolapse - Quantification system is a validated way to measure pelvic organ prolapse. The investigators will measure this post op at 1 year to see if prolapse is better using one method vs the other.
Pelvic Organ Prolapse - Quantification Point C
时间窗: 6-8 weeks post op
The Pelvic Organ Prolapse - Quantification system is a validated way to measure pelvic organ prolapse. The investigators will measure this post op at 6-8 weeks to see if prolapse is better using one method vs the other.
次要结局
- Vaginal Cuff Abscess(1 year)
- Vaginal Cuff Dehiscence(1 year)
- Vaginal Cuff bleeding(1 year)
- Vaginal Cuff Cellulitis(1 year)