2023-507732-20-00招募中3 期
A randomized double blind, multicenter trial to assess time-interval between cytoreductive surgery and adjuvant chemotherapy after administration of local anesthetic intraperitoneally/perioperatively in advanced epithelial ovarian cancer - IPLA-OVCA
Karolinska University Hospital, Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2023年8月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Time (days) to start of adjuvant chemotherapy after cytoreductive surgery
研究概览
简要总结
To investigate whether Ropivacaine 0.2% administered intraperitoneally during surgery and intermittently thereafter for up to 72 h in patients with stage III-IV epithelial ovarian cancer undergoing cytoreductive surgery leads to earlier start of adjuvant chemotherapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women > 18 years
- •Scheduled for upfront cytoreductive surgery for stage III or IV epithelial ovarian cancer
- •Signed written informed consent
排除标准
- •Contraindication to epidural anesthesia
- •Allergy to any component drugs used during epidural or intraperitoneal anesthesia (Ropivacaine, Sufentanil)
- •Uncontrolled renal, liver, heart failure or ischemic heart disease
- •Speech, language or cognitive difficulties
- •Women in whom cytoreductive surgery is not attempted at time of upfront laparotomy due to extent of disease
结局指标
主要结局
Time (days) to start of adjuvant chemotherapy after cytoreductive surgery
Time (days) to start of adjuvant chemotherapy after cytoreductive surgery
次要结局
- Postoperative complications, postoperative morbidity, quality of recovery, cardiac and renal impairment and overall survival
研究者
Sponsor representative
Scientific
Karolinska University Hospital
研究点 (2)
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