NCT02493972已完成不适用
Interest of the Manual Exploration as a Supplement to the Coelioscopy in the Evaluation of the Resectability of Peritoneal Carcinosis
Centre Francois Baclesse5 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- evaluate the number of patients with or without laparotomy after evaluation of the resectability by coelioscopy and coelioscopy more manual exploration
研究概览
简要总结
This is a Multicenter prospective diagnostic study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Over 18 years of age Patient
- •Woman presenting a peritoneal carcinosis presumed ovarian origin
- •Coelioscopy (1st intent or recurrence) planned or performed in the last 4 weeks for laparotomy. The peritoneal cancer index of Sugarbaker must be available.
- •WHO 0 - 2
- •Membership in a social security system
- •Patient having given her written consent
排除标准
- •Contraindication in the coelioscopy
- •Any associated medical or psychological condition which could compromise the capacity of the patient to participate in the study
- •Patient deprived of freedom, under guardianship or guardianship
研究组 & 干预措施
manual exploration by GelPort
Experimental
manual exploration in supplement of coelioscopy before laparotomy
干预措施: GelPort (Procedure)
manual exploration by GelPort
Experimental
manual exploration in supplement of coelioscopy before laparotomy
干预措施: laparotomy (Procedure)
结局指标
主要结局
evaluate the number of patients with or without laparotomy after evaluation of the resectability by coelioscopy and coelioscopy more manual exploration
时间窗: 1 month after inclusion
次要结局
- Number of patients with complications (eventrations, infections, pains) after manual exploration(1 month after inclusion)
- Number of patients with parietal metastases(1 month after inclusion)
研究者
研究点 (5)
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