Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy: a Randomized, Single-Blinded Study Comparing the Efficacy to the Routine Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Operation time
研究概览
简要总结
The use of the EnSeal® instrument for laparoscopic supracervical hysterectomy in a randomized, single-blinded comparison to the conventional procedure. The objective of the study is to investigate if the use of the Enseal sealing instrument for supracervical hysterectomy leads to a shortening of the operation time.
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
- •Age >18 years
- •Indication for supracervical hysterectomy without additional surgical procedures (i. e. oophorectomy)
- •Willingness and capability to comply with all study tests, procedures, and assessment tools
- •Capability of providing informed consent.
排除标准
- •History of, or evidence of, gynecologic malignancy within the past five years
- •Pace maker, internal defibrilator/cardioconverter
- •Impaired coagulation parameters
- •Unwillingness to be randomized to treatment
- •History of median laparotomy
- •Intraabdominal adhesions
- •Requirement for open laparoscopy
结局指标
主要结局
Operation time
时间窗: Day 1
The following times were documented: total operation time; T1 = start of the operation until cornual structures were ready to be dissected; T2 = the time from the first coagulation and cutting of the cornual structures until the complete preparation of each parametrial side directly before cervical detachment; T3 = time needed for the cervical detachment and subsequent steps (morcellation, closure of trocar sites) until the end of the surgical procedure.
次要结局
- Post-operative pain(Day 2)
- Blood loss(Day 2)
研究者
Bernhard Kraemer
Principal Investigator
University Hospital Tuebingen