Comparison of the Use of LigaSure, Halo PKS Cutting Forceps and Enseal Tissue Sealer in Total Laparoscopic Hysterectomy: a Randomised Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Perioperative Outcomes
研究概览
简要总结
There are many instruments with different energy modalities or with different properties that are available for use in total laparoscopic hysterectomy. The aim of the present study is to compare three of these instruments that are present in our clinic - HALO PKS Cutting Forceps, LigaSure and Enseal Tissue Sealer, in total laparoscopic hysterectomy with respect to operation time, blood loss, change in hemoglobin / hematocrit levels, perioperative complications, return of gastrointestinal activity and hospitalization 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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •any women with the indication of hysterectomy
排除标准
- •malignancy
- •having 3 or more previous abdominal surgeries
- •uterus being larger than 12 weeks of gestation
- •patients who must undergo additional surgical procedures during the same operation
结局指标
主要结局
Perioperative Outcomes
时间窗: Until 45 patients are operated (6 months anticipated)
Perioperative outcomes will be assessed with respect to complication rates, operation time, blood loss, change in hemoglobin and hemotocrit levels, time to return of gastrointestinal function and hospitalization time.
次要结局
未报告次要终点
研究者
Hakan Aytan
Associate Professor,
Adana Numune Training and Research Hospital