NCT04518449撤回不适用
the Medial Border Along the Left Side of SMA Versus the Left Side of SMV in Laparoscopic D3 Lymphadenectomy for Right Colon Cancer, a Prospective Cohort Study
Shanghai Minimally Invasive Surgery Center0 个研究点开始时间: 2022年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- incidence of diarrhea
研究概览
简要总结
This study investigats the gastrointestinal functional outcomes of laparoscopic D3 lymphadenectomy for right colon cancer with the medial border along the left side of superior mesenteric artery (SMA) versus the left side of superior mesenteric vein (SMV). This is a single center, prospective cohort study with a sample size of 264 patients. The primary endpoint is the incidence of diarrhea (evaluated using the Diarrhea Assessment Scale) one month after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •American Society of Anesthesiologists (ASA) score I to III
- •A biopsy proven histological diagnosis of colorectal carcinoma
- •tumor located at right half of colon
- •Undergoing laparoscopic right hemi-colectomy
- •preoperative staging cT2-4aN0M0 or cTanyN+M0
- •willing to participate and informed consent signed
排除标准
- •Pregnant or lactating women
- •Synchronous colorectal carcinoma
- •History of colorectal cancer or other malignant tumors
- •Clinical evidence of metastasis
- •Preoperative staging cT1N0 or cT4bNany
- •Emergency procedure
结局指标
主要结局
incidence of diarrhea
时间窗: one month after surgery
Diarrhea Assessment Scale: stool score ≥ 5
次要结局
未报告次要终点
研究者
Cai Zhenghao
Attending surgeon of gastrointestinal surgery，Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai Minimally Invasive Surgery Center
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