Comparing Two Devices of Uterine Manipulation and Vaginal Fornix Delineation at Total Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Colpotomy
研究概览
简要总结
We hypothesize, that the use of the Hohl manipulator® at total laparoscopic hysterectomy reduces operative time (from skin incision to detachment of the uterus) and lateral termal damage of the vaginal wall during colpotomy due to the following reasons: (1) Uterine manipulation is better with the Hohl manipulator®, thereby facilitating dissection during all aspects of the surgery, (2) more tension can be applied on the vagina during colpotomy, thereby hastening electrosurgical transection, reducing activation time and reduce lateral thermal damage and (3) tension on the vagina can be applied until the colpotomy is finished, due to the tight connection between the Hohl manipulator® and the cervix of the uterus, which also affects speed of transection, electrosurgical device activation time and lateral thermal damage.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women aged over 18 years, scheduled for a laparoscopic hysterectomy for a benign disorder will be asked to participate and included after written informed consent.
排除标准
- •pregnancy
- •malignancy
- •if uterine size exceeds 20 weeks of gestation
- •or if the uterus could be removed by a vaginal approach
结局指标
主要结局
Colpotomy
时间窗: 3 minutes to 20 minutes
Time from first monopolar energy activation to completion of colpotomy. Operative times are routinely collected by operating room nursing staff.
Detachment of the uterus
时间窗: 45 minutes to 3 hours
Operative time from skin incision to detachment of uterus. Times are routinely collected by operating room nursing staff.
Thermal Damage
时间窗: 2 weeks post surgery
Lateral thermal damage to the vagina will be measured on the specimen (in mm) at the time of pathologic evaluation.
次要结局
- Manipulator Installment(intraoperative)
- Blood Loss(45 minutes to 3 hours)
- Pain(24h post surgery)