EUCTR2013-002380-25-HR进行中（未招募）1 期
A Randomized, Open-label Study to compare Propofol Anaesthesia with Sevoflurane Anaesthesia in terms of Overall Survival in Patients with Surgical Intervention for either Breast-, Colon- or Rectalcancer
CKF at Västmanlands hospital Västerås0 个研究点目标入组 8,000 人开始时间: 2020年2月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 8,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Be informed of the nature of the study and have provided written informed consent
- •2.At least 18 years of age
- •3.Patient that is scheduled for elective radical breast- or colorectal cancer surgery in general anaesthesia. Radical surgery means that the aim of the surgery is to cure (adjuvant treatment such as chemotherapy and/or radiation therapy seen as part of the curative treatment)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5000
排除标准
- •1. The surgery that is going to be made is an emergancy surgical procedure
- •2. The surgery that is going to be made is palliative surgery
- •3. Known or suspected hypersensitivity to either propofol or sevoflurane or presence of any contraindication according to the substances’ valid SPC.
- •4. Lack of suitability for participation in the trial, for any reason, as judged by the Investigator (e.g. communicative disturbances (language or intellectual))
研究者
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A randomized study to evaluate whether there is a difference in survival between two different forms of anaesthesia. The study will evaluate patients that are scheduled for a surgery for either breast-, colon- or rectalcancer.Patients with breast- or colorectal cancer that will undergo radical surgery for this cancer. During the surgery general aneasthesia with either propofol or sevoflurane will be used.MedDRA version: 14.1Level: PTClassification code 10038038Term: Rectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10009944Term: Colon cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-002380-25-SECKF at Västmanlands hospital Västerås
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