JPRN-UMIN000007220已完成2 期
Comparison of therapeutic effect by number of access ports in laparoscopic surgery for colorectal cancer: Single-incision vs. Multi-port laparoscopic colectomy study (SIMPL study) (randomized phase II comparison study) - SIMPL study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
SILC is not superior to MPLC. 1.Even though the results of the 5-year OS and RFS in this trial were exploratory and underpowered, there were no statistically significant differences between the SILC and MPC arms. SILC may be an acceptable treatment option for select patients with colon cancer.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Severe hypersensitivity 2) Multiple cancer (Simultaneous or metachronous multiple cancer which disease-free interval is five years or less. However, a lesion of carcinoma in situ and intramucosal carcinoma are allowed.) 3) Active infectious disease 4) The past history of the mental disease and/or the central nervous system damage that becomes a clinical problem 5) Pregnant woman, lactating woman and woman who has possibility of pregnancy (intention). 6) Severe concomitant disease (Cardiorespiratory dysfunction, renal failure, intestinal paralysis, intestinal obstruction, uncontrolled diabetes melitus, liver cirrhosis and chronic hepatitis A and C, etc) 7) The past history of the organ transplantation 8) Preoperative treatment (chemotherapy, radiation therapy, and hormonal therapy, etc.) for colorectal cancer 9) Patient who judged that examination responsibility doctor is improper as subject of clinical trial
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