NCT02117557Unknown2 期
A Prospective Randomized Controlled Trial Comparing Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Guoxin Li1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2014年4月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Early morbidity rate
研究概览
简要总结
- Compared with traditional open colectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its short- and long-term oncologic outcomes have been demonstrated.
- In experienced surgeons' hands, single incision laparoscopic surgery is increasingly performed for colorectal disease, and even for malignant lesion because of its reduced incision-associated morbidity and scarring.
- However, the safety and efficacy of single incision laparoscopic surgery for colorectal cancer has not yet been evaluated. Thus, the prospective randomized trial comparing single incision versus conventional laparoscopic surgery for colorectal cancer is needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years < age < 80 years
- •Tumor located in rectosigmoid (defined as 10- to 30-cm from the anal verge)
- •Pathological rectosigmoid carcinoma
- •Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual
- •Tumor size of 5 cm or less; 6) ECOG score is 0-1
- •ASA socre is Ⅰ-Ⅲ
- •Informed consent
排除标准
- •Body mass index (BMI) >30 kg/m2
- •Pregnant woman or lactating woman
- •Severe mental disease
- •Previous abdominal surgery
- •Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
- •Requirement of simultaneous surgery for other disease
结局指标
主要结局
Early morbidity rate
时间窗: 30 days
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery,
次要结局
- Operative outcomes(intraoperative)
- Pathological outecomes(5 days)
- Postoperative recovery course(14 days)
- Pain score(14 days)
- Cosmetic assessment(14 days)
- 3-year disease free survival rate(36 months)
- 5-year overall survival rate(60 months)
- Inflammatory and immune response(7 days)
研究者
Guoxin Li
M.D., Ph.D.
Nanfang Hospital, Southern Medical University
研究点 (1)
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