ACTRN12618000372280招募中未知
Relook Laparoscopy for Peritoneal Surface Disease (ReLaPSeD) TrialA prospective randomised controlled trial comparing relook laparoscopy vs. standard follow-up for early detection and treatment of patients at high risk for peritoneal metastases after resection of colorectal cancer
Surgical Outcome Research Centre0 个研究点目标入组 194 人开始时间: 2018年3月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 194
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Resected colorectal adenocarcinoma (confirmed on histopathology) with complete oncological excision (i.e. clear resection margins),
- •AND, one or more of the following high-risk features:
- •i. Synchronous peritoneal or ovarian metastases that were resected completely at time of surgery
- •ii. Perforated tumour (including iatrogenic perforation)
- •iii. T4 tumour
- •iv. Mucinous T3 tumour
排除标准
- •i. Metastatic disease on preoperative staging
- •ii. Recurrent disease on staging after adjuvant chemotherapy
- •iii. Age < 18 or > 80
- •iv. ASA >3, ECOG >2
- •v. Tumour histology not colorectal adenocarcinoma
- •vi. Major uncontrolled medical comorbidity
- •vii. Medical conditions causing inability to give informed consent or comply with the study protocol
研究者
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