The Impact of Bipolar Energy Modalities on Peri-operative Outcome During Laparoscopic Staging Surgery of Gynecologic Cancers: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Duration of operation
研究概览
简要总结
This single-institution prospective randomized clinical trial will be performed at the Gynecologic Oncology clinic of Ankara University. Patients with endometrial cancer and cervix cancer who will be operated for staging via laparoscopic approach will be included in the study. The included patients will be randomized to two groups before surgery. During the operation of first group instruments with advanced bipolar energy will be used during lymphadenectomy and hysterectomy and salpingo-oophorectomy. In the second group the operation will be performed by conventional bipolar energy forceps. The outcome parameters to be measured are intra-operative bleeding, duration of operation, intraoperative complications, postoperative pain score, postoperative complications, postoperative duration of hospitalization, late complications such as lymphocele formation and costs.
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
- 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
- •Pathologic diagnosis of endometrial or cervix cancer
- •Stage I, IB1, IIA1 cervix cancer or patients with partial or complete response to chemoradiotherapy
- •Clinically stage I and II endometrial cancer
排除标准
- •Hematologic abnormality
- •Coagulation disorder
- •Present or past thromboembolic disease
- •ECOG performance >2
- •Advanced stage disease
- •Fertility preserving surgery
结局指标
主要结局
Duration of operation
时间窗: six months
Perioperative complications
时间窗: six months
次要结局
- Pain measured by Visual Analog Scale(Postoperative pain scores at 8th and 24th hours)
- Total cost of hospitalization, operation and complications(six months)
研究者
salih taskin
Assoc. Prof.
Ankara University
