Application of Overlap Method to Digestive Tract Reconstruction of Totally Laparoscopic Left Colectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The incidence of early complications
研究概览
简要总结
Objective:The comparison between total laparoscopic colectomy with intracorporeal anastomosis by overlap method and laparoscopic-assisted colectomy with extracorporeal anastomosis for colon cancer surgery.
Condition or disease：Left colon cancer Intervention/treatment： Procedure:Intracorporeal left colectomy Overlap anastomosis Procedure: Extracorporeal left colectomy convention anastomosis
详细描述
This a simple randomized, single-center, single-blind, randomized controlled trial study.The patients were randomly divided into experimental groups and control groups by computer.The perioperative recovery data, complications and oncology index of total laparoscopic colectomy with intracorporeal anastomosis and laparoscopic-assisted colectomy with extracorporeal anastomosis would be compared.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA<3 classification
- •18kg/m2≤BMI≤30kg/m2
- •Neoplasm staging is T1-4a, N0-2, M0
- •No previous history of abdominal surgery
- •No previous history of neoplasm chemoradiotherapy
- •No status of ileus, bowel obstruction and active hemorrhage of the digestive tract
排除标准
- •Age<18 years or >75 years
- •ASA≥3 classification
- •BMI<18kg/m2 or BMI>30kg/m2
- •Neoplasm staging is T4b or M1 Underwent chemoradiotherapy Appeared status of ileus,bowel perforation or active hemorrhage of digestive tract Patients with pregnant
结局指标
主要结局
The incidence of early complications
时间窗: one month after surgery
According to Clavein Dindo grading standards（The scale is divided into four levels, with the minimum（Ⅰ） and the maximum（Ⅳ） level. The higher the level that more severe symptoms.）, the incidence of complications within one month after surgery, such as incision infection, bleeding, anastomotic leakage, ileus, etc., was counted
次要结局
- anastomotic orifice stricture and torsion(one month after surgery)
- the time of first flatus(one month after surgery)
- the time of first defecation(one month after surgery)
- the time of first oral feeding(one month after surgery)
- postoperative hospitalization days(one month after surgery)
- the incision length and cosmetic(one month after surgery)
- pain score(postoperative 6 hours, the first day and the third day)