Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- short-term morbidity rate
研究概览
简要总结
The main goal of this study is to clarify if laparoscopy (LPS) could become the standard approach in patients undergoing left colonic resection.
268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or open (n=134) approach. Postoperative care protocol was the same in both groups. Trained members of the surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term morbidity, quality of life, and 5-year survival have also been evaluated.
详细描述
The study design was explained to the potential participants who were asked to sign a written informed consent before randomization.
Eligible patients were randomly allocated to LPS or open surgery. Randomization list was computer generated. Assignments were made by means of sealed sequenced masked envelopes which were opened, before the induction of anesthesia, by a nurse unaware of the trial design.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •suitability to elective surgery
排除标准
- •cancer infiltrating adjacent organs assessed by computed tomography
- •cardiovascular dysfunction (New York Heart Association class > 3)
- •respiratory dysfunction (arterial pO2 < 70 mmHg)
- •hepatic dysfunction (Child-Pugh class C)
- •ongoing infection
- •plasma neutrophil level < 2.0x109/L
结局指标
主要结局
short-term morbidity rate
时间窗: 30 days
次要结局
- long-term outcome(5 years)