Prospective Randomized Trial of Incisionless Versus Conventional Laparoscopic Colectomy for Left-sided Colonic Tumors
研究概览
地位
详细说明
For the left-sided colorectal cancer, the investigators performed colectomy with primary anatomosis. Currently the investigators have two methods of minimal access approach to the abdominal cavity in order to complete this operation:
- Conventional Laparoscopic colectomy The operation is completed by laparoscopic instruments using video laparoscopy. At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler. Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis
- Incisionless Laparoscopic Colectomy Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the Transanal Endoscopic Operation (TEO) device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy. Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.
These two operations are essentially identical except for the surgical access for the delivery of specimen and insertion of anvil. Laparoscopic colectomy and the use of Transanal Endoscopic Operation(TEO)device have been practiced in the United States and Europe for over 10 years. Large scale studies in the literature have demonstrated the safety and benefits of laparoscopic colectomy for colonic tumors and the oncological outcomes have not shown to be inferior to open approach. With the use of TEO device, the investigators can perform laparoscopic colectomy without abdominal incision for those early left-sided colonic tumors and thus it can eliminate the wound-related complications theoretically. In order to find out which one is a better procedure, the investigators are carrying out a clinical trial to compare the two surgical options in their short-term and long term outcomes.The results of this study may have an impact on the care of similar patients in the future.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hong Kong、中国
- Department of Surgery, Pamela Youde Nethersole Eastern Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
patients >18 years old and diagnosed to have operable left-sided colorectal cancers distal to the splenic flexure and proximal to the upper rectum were potential candidates.
Exclusion Criteria:
- Patient who did not give informed consent;
- Patient who were considered unfit for operative treatment;
- Patient presented as acute surgical emergencies, including intestinal obstruction, peritonitis, or pericolic abscess, etc.;
- Patients with metastatic diseases on preoperative work up;
- Patient with synchronous tumours or polyps which necessitate extended or additional resection;
- Patients with large bulky tumor as demonstrated on preoperative colonoscopy or computed tomography showing serosal involvement or invasion to contiguous organs.
- Patients with anal stenosis that precluded the insertion of TEO device
学习计划
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：incisionless laparoscopic colectomy
incisionless laparoscopic colectomy: Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the TEO device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy.
Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.
|
Arm 1:Incisionless Laparoscopic Colectomy Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the TEO device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy.
Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.
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有源比较器：conventional laparoscopic colectomy
conventional laparoscopic colectomy: The operation is completed by laparoscopic instruments using video laparoscopy.
At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler.
Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis
|
Arm 2: Conventional Laparoscopic colectomy The operation is completed by laparoscopic instruments using video laparoscopy.
At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler.
Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis
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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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pain score
大体时间：average of 1 week
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participants will be followed for the pain score during the duration of hospital stay, an expected average of 1 week
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average of 1 week
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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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wound complication
大体时间：up to 30 days after the operation
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The patient will be followed for up to 30 days after the operation or till occurrence of event
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up to 30 days after the operation
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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intraoperative blood loss
大体时间：From the start of operation till operation finished
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From the start of operation till operation finished
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From the start of operation till operation finished
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operative time
大体时间：From the start of operation till operation finished
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From the start of operation till operation finished
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From the start of operation till operation finished
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length of hospital stay
大体时间：From the date after operation to date of discharge,an expected average of within 1 week
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From the date after operation to date of discharge,an expected average of within 1 week
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From the date after operation to date of discharge,an expected average of within 1 week
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合作者和调查者
调查人员
- 首席研究员：Yui Shan Cheung, FRACS、Department of Surgery, Pamela Youde Nethersole Eastern Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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