Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer
2016年9月1日 更新者：Zhixiang Zhou、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
A Prospective Randomized Controlled Trial Comparing Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) Versus Conventional Laparoscopic Surgery for Sigmoid Colon or Rectal Cancer
The purpose of this study is to compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or rectal cancer.
研究概览
详细说明
Further study details as provided by Chinese Academy of Medical Sciences.
研究类型
介入性
注册 (预期的)
366
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zhixiang Zhou, M.D.
- 电话号码：+86-139-1123-2981
- 邮箱：Dr_zhouzx@163.com
研究联系人备份
- 姓名：Jianwei Liang, M.D.
- 电话号码：+86-130-7119-7461
- 邮箱：liangjw1976@126.com
学习地点
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Beijing
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Beijing、Beijing、中国、100021
- 招聘中
- Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
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首席研究员：
- Zhixiang Zhou, M.D.
-
接触：
- Zhixiang Zhou, M.D.
- 电话号码：+86-139-1123-2981
- 邮箱：Dr_zhouzx@163.com
-
接触：
- Jianwei Liang, M.D.
- 电话号码：+86-130-7119-7461
- 邮箱：liangjw1976@126.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 18 years < age < 80 years
- Tumor located in rectosigmoid (defined as 8- to 30-cm from the anal verge)
- Pathological rectosigmoid adenocarcinoma
- Preoperative T stage ranging from T1 to T4a according to the 7th Edition of American Joint Committee on Cancer (AJCC) Staging Manual
- Tumor size of 6 cm or less;
- Eastern Cooperative Oncology Group (ECOG) score is 0-1
- American Society of Anesthesiology (ASA) score is Ⅰ-Ⅲ
- Informed consent
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：常规腹腔镜手术
本组患者将接受常规腹腔镜结直肠癌手术。
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High ligation of inferior mesenteric vessel , mobilization of bowel, and dissection of lymph nodes were performed laparoscopically, and total mesorectal excision with nerve-sparing technique was followed for rectal cancer.
Conventional laparoscopic-assisted surgery (CLS), a small incision with a 3-7cm length was made in hypogastrium, transection of rectum was completed through abdominal incision, then the specimen was removed and the bowel was prepared for anastomosis.
The anastomosis for all rectal cancer and most of sigmoid colon cancer was performed by a double-stapling technique following open resection.
其他名称：
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实验性的：transrectal specimen extraction
Laparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group.
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After mobilization of bowel and dissection of lymph nodes, a cross clamp was placed distal to the tumor.
Distal rectum was transected after fully disinfecting rectal lumen by 10% povidone-iodine.
An anvil head attached to circular stapling device was put into abdominal cavity through rectal stump, and put into colon lumen through a longitudinal incision, then the proximal colon was transected in close proximity to the upper pole of incision by a linear stapling device.
During specimen extraction though the rectum, a disposable sterile protective cover was used to avoid cancer cell exfoliation and implantation.
The rectal opening was reclosed by a linear stapler.
End-to-end colorectal anastomosis was performed with a circular stapler using the double-stapling technique.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Early morbidity rate
大体时间：30 days
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The early morbidity rate is defined as the event observed during operation and within 30 days after surgery.
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30 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Duration of the intervention
大体时间：1 day
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Duration of surgery.
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1 day
|
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Peritoneal bacterial contamination
大体时间：1 day
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Peritoneal fluid samples were collected under sterile conditions at the end of the procedure and sent for gram stain as well as anaerobic, aerobic, and fungal cultures.We assess the contamination rate of peritoneal fluid in the two interventions.
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1 day
|
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Pain score
大体时间：14 days
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Recording of the needed analgesia guided by pain score
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14 days
|
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3-year disease free survival rate
大体时间：3 years
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A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
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3 years
|
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5-year overall survival rate
大体时间：5 years
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A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
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5 years
|
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Plasma levels of several cytokines after colorectal cancer surgery
大体时间：7 days
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We have measured and compared perioperative plasma levels of interleukin-2, interleukin-6, interleukin-8, C-reactive protein and procalcitonin in the two group sample.
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7 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Zhixiang Zhou, M.D.、Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年11月1日
初级完成 (预期的)
2020年12月1日
研究完成 (预期的)
2025年12月1日
研究注册日期
首次提交
2015年11月30日
首先提交符合 QC 标准的
2015年12月16日
首次发布 (估计)
2015年12月21日
研究记录更新
最后更新发布 (估计)
2016年9月2日
上次提交的符合 QC 标准的更新
2016年9月1日
最后验证
2016年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.