Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,141
- 试验地点
- 14
- 主要终点
- Comprehensive complication index
研究概览
简要总结
The complication rate in colorectal surgery is high and shows a large variance depending on the patient and the treating surgeon. The primary aim of the presented study is to evaluate the introduction of a colorectal bundle to reduce the complication rate in left sided colorectal resections. The colorectal bundle is a catalog of measures consisting of several items These are for example preoperative risk stratification, antibiotic and mechanical bowel preparation and preoperative showering. The primary endpoint will be the complication rate measured as the comprehensive clinical index (CCI) within 30 days. Investigators will include patients that undergo elective or emergency left sided colorectal surgery.
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
- •aged ≥ 18 years
- •Patients undergoing any left sided emergency or elective colorectal resections
- •Patients should have given or will give a general consent
排除标准
- •no general consent given
- •unable to provide informed general consent
- •vulnerable patients (Age < 18 years or patients with severe dementia)
- •the intervention is a reoperation within 30 days of primary operation
- •Exclusion criteria for an antibiotic decontamination subgroup:
- •known allergy to one of the applied antibiotic regimes
- •active bacterial infection requiring systemic antibiotics
- •IV or oral antibiotics in past 7 days prior to the planned decontamination
- •terminal kidney disease
- •unable to take antibiotic decontamination medication
- •pregnancy or breastfeeding
- •emergency or expedited surgery
研究组 & 干预措施
Control Arm
Patients are treated according to current local standards
Colorectal Bundle Arm
Patients are treated according to the colorectal bundle
干预措施: Colorectal Bundle (Procedure)
结局指标
主要结局
Comprehensive complication index
时间窗: 30 days
The primary endpoint is the comprehensive complication index (CCI) at 30 days after the index procedure, a continuous scale to measure surgical morbidity that has been developed on the basis of the Clavien Dindo Classification for surgical complications and summarizes and weighs all postoperative complications to a scale from 0 (no complications) to 100 (death of the patient) .
次要结局
- Contribution margin(immediately after discharge)
- Surgical side infections(30 days)
- Number of patients who died within 30 days(30 days)
- Rate of anastomotic leakage(30 days)
- Hospital length of stay(immediately after discharge)