Open Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision and Central Vascular Ligation for Right Colon Cancer. A Randomized Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- the number of lymph nodes (LNs) harvested among both groups
研究概览
简要总结
The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.
详细描述
The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.
Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
The primary outcome was the number of lymph nodes (LNs) harvested among both groups. Secondary outcomes included operative time, blood loss, postoperative complications, and hospital stay.
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)
盲法说明
Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with right colonic cancer
排除标准
- •Patients with distant metastasis, large tumors with extra-colonic invasion emergency presentation (bowel obstruction or perforation)
结局指标
主要结局
the number of lymph nodes (LNs) harvested among both groups
时间窗: 30 DAYS
the number of lymph nodes (LNs) harvested among both groups
次要结局
- blood loss,(intraoperative)
- operative time(INTRAOPERATIVE)
- post-operative complications(30 days)
研究者
Ayman El Nakeeb
gastrointestinal surgical center, Mansoura University
Mansoura University