Electrosurgery Wars;Ligasure or Enseal in Total Laparoscopic Hysterectomy: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 主要终点
- Operative time
研究概览
简要总结
The effect of two different bipolar instruments were compared in terms of operative time, total operative time, intra-operative blood loss and intra-operative and postoperative complications. Devices included the LigaSure™ Maryland Jaw 5 mm laparoscopic instrument (LigaSure; LF 1737, Covidien, Mansfield, MA, USA) and ENSEAL™ G2 Articulating Straight 5mm Tissue Sealer (ENSEAL; NSLG2S35A, Ethicon Endo-surgery, US, LLC).
详细描述
This study is a single-center, single-blinded, randomized control trial that was conducted at the University of Health Sciences Antalya Training and Research Hospital.
The study was single-blinded in that the patient was not informed of their group assignment; it is impossible to blind the surgeon using the devices.
Methods and Procedures:
Patients were recruited from outpatient clinics and informed about the study before enrollment. Women aged over 18 years scheduled for laparoscopic hysterectomy for benign indications between June 2016 and November 2017 were included in the study after obtaining written consent.
Women who had given consent were randomized one day before surgery to one of two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age 18 or older
- •Able and willing to provide informed consent
- •Undergoing total laparoscopic hysterectomy
排除标准
- •Under 18 years of age
- •Suspected malignancy
研究组 & 干预措施
Ligasure device
This group of women undergoing hysterectomy were randomized to the Ligasure energy device
干预措施: Ligasure device (Device)
Articulating Enseal
This group of women undergoing hysterectomy were randomized to the articulating Enseal energy device
干预措施: Articulating Enseal (Device)
结局指标
主要结局
Operative time
时间窗: 16 months
Defined as time from start of sealing and transection of the round ligament until start of colpotomy, was the primary endpoint.
次要结局
- Total operative time(16 months)
- Intra-operative complications(16 months)
- Intra-operative estimated blood loss(16 months)
研究者
Burak Karadag, MD
Associate Professor
Antalya Training and Research Hospital