NCT01814579Unknown不适用
Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy, a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Vaginal Cuff Closure Time
研究概览
简要总结
This study is designed to determine if using the V-Loc Wound Closure System expedites operative time in robotic hysterectomy.
详细描述
Currently both traditional continuous smooth suture and unidirectional barbed suture techniques are standard of care in robotic hysterectomy and the decision of which to use is at the discretion of the surgeon. By using unidirectional barbed suture in which no knot tying is required, wound closure time may be decreased resulting in decreased operative time. This study was created to compare vaginal cuff closure times using these two techniques.
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
- •Women being scheduled to have a robotic hysterectomy for benign or malignant disease by the West Clinic Gynecology-Oncology Physicians
- •Females age 18+
排除标准
- •Patients receiving ongoing radiation therapy to the pelvis
结局指标
主要结局
Vaginal Cuff Closure Time
时间窗: At time of surgery
Vaginal cuff closure time will be timed at time of robotic hysterectomy.
次要结局
- Vaginal Cuff Dehiscence(Post Operatively (3 months))
- Vaginal Cuff Evisceration(Post Operatively (3 months))
- Vaginal Cuff Granulation Tissue Formation(Post Operatively (3 months))
研究者
Adam Mabe
Resident Physician
University of Tennessee
研究点 (4)
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