Comparison of BiCision® Versus UltraCision® During Laparoscopic Supracervical Hysterectomy (LASH): A Prospective, Controlled, Randomized, Non-inferiority in Vivo Human Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Operation time
研究概览
简要总结
The aim of the study is the evaluation of the efficiency and safety of the new, CE-certified thermofu-sion and dissection instrument BiCision® in comparison with the long established Ultracision® Har-monic Scalpel(Ethicon)during a laparoscopic supracervical hysterectomy (LASH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •age > 18
- •gender: female
- •indication for laparoscopic supracervical hysterectomy with no adnexectomyor other surgery
- •will and the capability to comply the study requirements
- •signed informed consent
排除标准
- •Invasive malignome in the pelvis
- •Cardiac pacemaker or implanted defibrilator if no informations are available about the compatibil-ity with RF energy
- •Abnormal blood parameters (values less than factor 0.8 or more than 1.25 compared to the val-ues of creatinine and standard hemogram)
- •Abnormal coagulation parameters: PTT > 40 sec. and / or Quick's-Value< 50% (the use of antiplateletsup to a max. of 100mg/d is no exclusion criteria)
- •Inability to understand the purpose of the study
- •status after a laparotomy by a longitudinal incision
- •intraabdominal adhesions (at the beginning of the surgery ≥ 5 sectioning for adhesiolysis)
- •open laparoscopy required
- •different anatomical situations that yields to different surgery requirements
- •conspicuous PAP, cervixmyoma or endometriosis of the rectovaginale space
结局指标
主要结局
Operation time
时间窗: Participants will be followed for the duration of hospital stay, an expexted average of 8 months
The primary objective is the operation time for each preparation side and instrument needed from the beginning of the removal of the cornual structure of the uterus (uterine cornu) till the completely removal of the parametric tissue directly before removal of the corpus uteri from the cervix.
次要结局
未报告次要终点
研究者
Bernhard Kraemer
Executive / Investigator
University Hospital Tuebingen