NCT01609361已完成不适用
Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Post operative morbidity at 30 days according to DINDO CLAVIEN classification
研究概览
简要总结
Rehabilitation program improves operative results following conventional open colorectal surgery. Very few data are available on such program in laparoscopic colorectal surgery.
详细描述
The aim is to assess rehabilitation program in laparoscopic colorectal surgery in terms of 30 days peri operative complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
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 old
- •Colorectal cancer
- •Inform and consent form signed
- •Patient has valid health insurance/coverage
- •Functional capacity ≥ 4 METs (metabolic equivalents) (up 1 floor without stopping, walking down the street 5-7km / h, major domestic activities)
- •Patients with laparoscopic resection for colorectal cancer including abdominoperineal resection
- •Inclusion Criteria (arm : Laparoscopy + Rehabilitation program):
- •Tobacco and alcohol weaning
排除标准
- •MBI < 18kg/m2
- •severe malnutrition
- •Metastatic colorectal cancer
- •Buzby Index <83
- •Combined surgery (hepatic resection or segmental resection of small intestine)
- •Urgent surgery
- •Pregnancy or maternal breastfeeding
- •Body mass index (BMI)> 30 kg/m2
- •Abdominoperineal resection
- •Subtotal colectomy
- •Total proctocolectomy
- •Cons to Naropin Xylocaine, droperidol, ketamine
- •Patient with a history of peptic ulcer
结局指标
主要结局
Post operative morbidity at 30 days according to DINDO CLAVIEN classification
时间窗: 30 days
Post operative morbidity at 30 days according to DINDO CLAVIEN classification (grade I to IV)
次要结局
- Mortality according to DINDO CLAVIEN classification(up to 30 days)
- Hospital stay and readmissions(up to first month)
- Intravenous perfusion stay(participants will be followed until the end of hospitalization an expected average of 2 weeks)
- Specific (GIQLI) quality of life(Preoperative and at 1, 3, 6 months)
- Duration of laxation (gas and stool)(up to hospital discharge)
- Global (SF36) quality of life(Preoperative and at 1, 3, 6 months)
研究者
研究点 (2)
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