ESCP Safe Anastomosis proGramme in coLorectal surgEry
试验速览
- 阶段
- 不适用
- 入组人数
- 4,400
- 试验地点
- 1
- 主要终点
- Number of patients diagnosed clinically or radiologically with anastomotic leak within 30 days of surgery
研究概览
简要总结
EAGLE is an international service improvement study to investigate the value of an educational tool delivered to surgeons and their teams to reduce the risk of anastomotic leak (leak of a join in the bowel) after right hemicolectomy or ileocaecal resection. This complication causes significant risk to life and therefore risks of leak should be minimised.
The educational team of the European Society of Coloproctology has developed an online training package to deliver to 350 hospitals in 30 countries.
详细描述
EAGLE is an international quality improvement programme to share best practice and harmonise ileo-colic anastomosis procedures through an education programme for surgeons and theatre teams.
The programme has 3 main strategies: (i) enhanced pre-operative risk stratification (making sure it is safe to join the bowel together for each patient); (ii) harmonisation of surgical technique (making the join as good as it can be and checking it carefully after it is created), and (iii) implementation of an intra-operative anastomosis 'checklist' (focusing the attention of the whole theatre team at this critical stage of the operation). The investigators will use a novel scientific approach to assess the patient benefit that enables not only the quality improvement itself to be delivered to all participating hospitals but also enables collection and analysis of data to measure the effect of these measures. The best way of doing this is to embed the proposed quality improvement into a staggered implementation programme, allowing the effect to be assessed between the centres. The specific methodology proposed introduces the intervention in a step-wise fashion to all hospitals. By the end, all sites will have implemented the programme. Overall, the investigators hope to reduce the leak rate by 30% from 8.1% to 5.6% in about 4,500 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patient will be blinded to their hospital's randomised sequence allocation. Analysis will be performed blind to allocation sequence (and therefore before and after status) and after data have been cleaned and locked.
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
- •All adult patients (age 18 years and above) undergoing right colectomy with or without primary anastomosis. Right colectomy is defined as ileocaecal resection or right hemicolectomy (any colonic transection with the distal resection margin proximal to the splenic flexure).
- •All patients undergoing right colectomy are eligible, including those who do not have an anastomosis and are defunctioned by a proximal stoma.
- •Procedures for any pathology, via any operative approach (open, laparoscopic, robotic or converted) are eligible.
- •Elective (surgery on a planned admission), expedited, and emergency (surgery on an unplanned admission) procedures are eligible.
排除标准
- •Patients undergoing more than one gastrointestinal anastomosis during the same operation.
- •In Crohn's disease, additional upstream stricturoplasty or resection/anastomosis to treat disease or strictures at the same operation.
- •Simultaneous right colectomy and hyperthermic intraperitoneal chemotherapy (HIPEC) and/or cytoreductive surgery.
- •Each individual patient should only be included in EAGLE once. Following the index procedure that is included in EAGLE, patients undergoing additional procedures within the study window should not be included for a second time.
结局指标
主要结局
Number of patients diagnosed clinically or radiologically with anastomotic leak within 30 days of surgery
时间窗: up to 30 days from operation
Anastomotic leak is defined as anastomotic leak identified radiologically or clinically, or intra-peritoneal (abdominal or pelvic) fluid collection identified radiologically, as per the Centre for Disease Control Criteria for Organ Space infection. This will be described as a rate divided by the total number of patients who had a primary anastomosis (rather than total number of patients undergoing right hemicolectomy or ileocaecal resection).
次要结局
- Length of hospital stay following right hemicolectomy or ileocaecal resection(up to 30 days)
- The rate of re-operation for anastomotic leak(up to 30 days)
- The rate of adverse outcomes following right hemicolectomy or ileocaecal resection(up to 30 days)
- The rate of stoma formation(At index operation)