跳至主要内容
临床试验/NCT02822820
NCT02822820已完成不适用

The Impact of Bipolar Energy Modalities on Peri-operative Outcome During Laparoscopic Staging Surgery of Gynecologic Cancers: A Randomized Clinical Trial

Ankara University2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2016年7月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

salih taskin

Assoc. Prof.

Ankara University

研究点 (2)

Loading locations...

相似试验