NCT02830633Unknown2 期
Trial to Evaluate Laparoscopy-assisted Nerve-preserved Total Mesorectal Excision (LNTME) Versus Open TME for Rectal Cancer
Anhui Medical University0 个研究点目标入组 80 人开始时间: 2016年7月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 主要终点
- Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions.
研究概览
简要总结
The purpose of this study is to determine: (1) whether laparoscopy-assisted nerve-preserved total mesorectal excision (LNTME) is as safe as open TME for rectal cancer, and (2) whether LNTME is more effective for protection of pelvic autonomic nerve function from surgical impairing when comparing to open TME.
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients
- •From 18 years old to 60 years old
- •Normal sexual function
- •Tumor located in rectum (defined as 5- to 12-cm from the anal verge)
- •Pathological confirmed rectal cancer
- •Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual
- •Tumor size < 5 cm
- •ASA score was I-II
- •Informed consent was written
排除标准
- •Distant cancer metastasis
- •History of abdominal surgery
- •With other type of malignancy
- •Preoperative voiding dysfunction
- •Preoperative sexual dysfunction
- •Refusing to attend this trial
结局指标
主要结局
Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions.
时间窗: postoperative 30 days
The postoperative sexual function assessed by IIEF questionnaire
时间窗: postoperative one year
The postoperative voiding function assessed by IPSS questionnaire.
时间窗: postoperative one year
次要结局
- Operative time(an expected average of 180 minutes)
- Postoperative deaths(postoperative 30 days)
- The length postoperative hospital stay(an expected average 8 days)
- C-reactive protein(postoperative 7 days)
研究者
Han-Hui YAO
M.D.
Anhui Medical University
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