NCT03130166已完成不适用
Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy - a Double-blinded Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Postoperative recovery
研究概览
简要总结
Right-sided colonic cancer is treated with right-sided colectomy, predominantly performed as minimally invasive surgery with extracorporeal anastomosis (ECA). In recent years a new technique with intracorporeal anastomosis (ICA) has emerged and it is thought that ICA is less invasive and thereby has the potential to improve the postoperative course of right colonic cancer patients.
The objective of this study is to compare robotic right colectomy with either ICA or ECA in a randomized controlled setting.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients scheduled for robotic right colectomy due to colonic cancer are eligible for inclusion.
排除标准
- 未提供
结局指标
主要结局
Postoperative recovery
时间窗: 1 month
Questionnaire of Recovery 15 (QoR-15)
次要结局
- Mortality(1 month)
- Postoperative pain(1 month)
- Whole blood gene expression profiling(1 month)
- Length of hospital stay(1 month)
- Morbidity(1 month)
- Heart Rate Variability(2 days)
- Ortostatic hypotension test(2 days)
- Postoperative opioid usage(1 month)
- Time to first bowel movement(1 month)
- Spirometry and PEF - test(2 days)
- Time fo first flatus(1 month)
- "Timed up and go"-test(2 days)
研究者
Niclas Dohrn
MD.
Herlev and Gentofte Hospital
研究点 (2)
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