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临床试验/NCT01549925
NCT01549925已完成不适用

A Prospective Randomized Surgical Trial Comparing the Efficacy of LIGASURE Assisted Recto-Sigmoid Resection and Omentectomy Compared to Standard Surgical Resection in Women With Stage IIIC or Stage IVA Epithelial Ovarian Cancer

University of Utah4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年1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
50
试验地点
4
主要终点
Surgical Time

研究概览

简要总结

The objective of this prospective randomized surgical trial is to evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures.

详细描述

This research study is a prospective, randomized trial. Women who are suspected to have an early or late stage ovarian cancer during their preoperative evaluation will be potential study participants. Only patients with documented ovarian cancer by histologic examination at the time of the cytoreductive or staging surgery, and that are also undergoing omentectomy and/or recto-sigmoid colon resection will be eligible for participation. Patients who are eligible for participation and who are willing to participate will be randomized during the surgical procedure to standard surgical resection using clamps and surgical ligatures versus resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon. The resection of these tissues will be performed as part of the usual surgical protocol for women with ovarian cancer and will not be done so unless the tissues are the sites of metastatic disease or if their removal would be performed for staging purposes.

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

  • Patients must be 18 years or older
  • All patients who are suspected to have an early or late stage ovarian cancer during their preoperative evaluation will be potential study participants.
  • Potential candidates must have signed an IRB-approved Informed Consent (University of Utah Informed consent if their surgery will be performed at the Huntsman Cancer Hospital, or Intermountain Health Care consent if the surgery is to be performed at LDSH or IMC.
  • Only patients with documented ovarian cancer by histologic examination at the time of the cytoreductive or staging surgery, and that are also undergoing omentectomy and/or recto-sigmoid colon resection will be eligible for participation.

排除标准

  • 未提供

结局指标

主要结局

Surgical Time

时间窗: at time of surgery, up to 10 minutes

To evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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