NCT03843398尚未招募不适用
Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 992
- 主要终点
- 3-year overall survival, 3y OS
研究概览
简要总结
The primary aim of this study is
- to determine the difference of survival outcome (3-year overall survival, 3y OS) between after minilaparotomy and after laparoscopy..
Other aims include to determine the data below when minilaparotomy and laparoscopy are compared with each other.
- 3-year disease free survival, 3y DFS
- 5-year overall survival, 5y OS
- 5-year disease free survival, 5y DFS
- Local recurrence rate, LRR
- Postoperative complications Incidence and mortality at 30 days
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
- •Colorectal cancer with pathological results.
- •Colorectal cancer preliminary diagnosed during colonoscopy.
- •No confirmed metastasis.
- •No comorbidity of other malignancy.
- •The primary tumor is less than 10 cm.
- •No organ dysfunction.
- •The patient and his families totally agree with the whole investigative procedure, and sign the written informed consent form.
排除标准
- •Diagnosed with any other malignancy within 5 years.
- •Comorbidity of emergent conditions like perforation.
- •Former colorectal surgery history which may affects digestive tract reconstruction.
- •Need combined organ resection.
- •ASA grade IV or V.
- •Pregnant or lactating Women.
- •Severe mental diseases.
- •Severe cardiopulmonary diseases which reduce operation tolerance.
- •Systematic steroid therapy lasting for more than 1 month.
- •Intolerant of laparoscopy.
- •No written informed consent form signed.
研究组 & 干预措施
Minilaparotomy Group
Experimental
Participants in this arm undergo colorectal cancer resection via minilaparotomy.
干预措施: Colorectal cancer resection via minilaparotomy (Procedure)
Laparoscopy Group
Active Comparator
Participants in this arm undergo laparoscopic colorectal cancer resection.
干预措施: Laparoscopic colorectal cancer resection (Procedure)
结局指标
主要结局
3-year overall survival, 3y OS
时间窗: 3 years after the follow up of the last patient enrolled.
3y OS
次要结局
- 3-year disease free survival, 3y DFS(3 years after the follow up of the last patient enrolled.)
- Postoperative mortality at 30 days(30 days after the operation of the last patient enrolled.)
- Postoperative complications Incidence at 30 days(30 days after the operation of the last patient enrolled.)
- 5-year overall survival, 5y OS(5 years after the follow up of the last patient enrolled.)
- Local recurrence rate, LRR(3 years after the follow up of the last patient enrolled.)
- 5-year disease free survival, 3y DFS(5 years after the follow up of the last patient enrolled.)
研究者
En-Da Yu
Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy
Changhai Hospital
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