The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time from when a subject lies on the OR table to fascial closure
研究概览
简要总结
This is an unblinded, randomized control trial of obese women to evaluate the impact of the Traxi Panniculus Retractor (TPR) on the cesarean operative time and surgical blood loss when compared to silk tape.
详细描述
The purpose of the study is to assess whether using the Traxi Panniculus Retractor during cesarean section, in obese (BMI greater than or equal to 30kg/m2 at time of delivery) women, can decrease the cesarean operative time compared to using silk tape to retract the panniculus. Operative time is defined as the time from when the patient lies on the operating room table (at completion of the epidural/spinal anesthesia) until fascial closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
No Masking
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Current BMI equal to or greater than 30 kg/m2 at last prenatal visit or on day of admission to L&D
- •Requires panniculus retractor for cesarean delivery, as determined by the surgeon
- •Non-emergent cesarean delivery
- •Spinal or epidural anesthesia
- •Low transverse skin incision
- •Gestational age equal to or more than 32 weeks 0 days
- •Singleton pregnancy
- •Three or less previous cesarean deliveries.
- •English speaking
排除标准
- •Use of Alexis or any other retractor
- •General anesthesia
- •Fetal demise
- •Placenta previa
- •History of bariatric surgery
- •Adhesive allergy
结局指标
主要结局
Time from when a subject lies on the OR table to fascial closure
时间窗: During surgery-Time from when a subject lies on the OR table to fascial closure
次要结局
- Time from skin incision to delivery(During surgery-skin incision to delivery)
- Time from hysterotomy to delivery(During surgery-hysterotomy to delivery)
- Time from skin incision to closure of fascia(During surgery-skin incision to closure of fascia)
- Time from skin incision to skin closure(During surgery-skin incision to skin closure)