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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
4,400
The intervention is the same in each arm; the EAGLE Safe Anastomosis Quality Improvement Intervention is an educational programme for behavioural change composed of three parts: 1. Introduction of a routine patient risk stratification for anastomotic leak 2. Implementation of the ESCP Safe Anastomosis Checklist 3. Adoption of a harmonised technique for stapled and handsewn anastomosis based on best evidence.
Clinic of Coloproctology and Minimally Invasive Surgery
Moscow, Russia
RECRUITINGNumber of patients diagnosed clinically or radiologically with anastomotic leak within 30 days of surgery
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).
Time frame: up to 30 days from operation
The rate of re-operation for anastomotic leak
The number of patients re-operated, of those diagnosed with anastomotic leak following right hemicolectomy or ileocaecal resection
Time frame: up to 30 days
The rate of adverse outcomes following right hemicolectomy or ileocaecal resection
For all patients included in the study (i.e. who underwent right hemicolectomy or ileocaecal resection whether or not with primary anastomosis); 1. Number of patients undergoing re-operation for any cause within 30 days 2. Number of patients with unplanned admission to critical care within 30 days 3. Number of patients re-admitted to hospital within 30 days 4. Mortality rate within 30 days
Time frame: up to 30 days
The rate of stoma formation
For all patients included in the study (i.e. who underwent right hemicolectomy or ileocaecal resection whether or not with primary anastomosis); 1. Rate of formation of ileostomy without primary anastomosis 2. Rate of defunctioning ileostomy with primary anastomosis
Time frame: At index operation
Length of hospital stay following right hemicolectomy or ileocaecal resection
Measured in post-operative days
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Time frame: up to 30 days