An interventional study of The EAGLE Safe Anastomosis Quality Improvement Intervention in Anastomotic Leak and Anastomosis; Complications, sponsored by University of Birmingham. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-29.
Sponsored by University of Birmingham · Not applicable, Interventional, and Prevention
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.
209 studies on the registry are indexed under Anastomotic Leak; 60 are open to participants now.
This study's planned enrollment of 4,400 is above the median of 121 across 100 interventional studies indexed under Anastomotic Leak.
Browse Anastomotic Leak studies →University of Birmingham is the lead sponsor of 179 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
'After intervention' group receives the training immediately and data are only collected after the intervention.
Behavioral: The EAGLE Safe Anastomosis Quality Improvement Intervention
For the 'Before and after intervention' group, data are collected both before and after the training.
Behavioral: The EAGLE Safe Anastomosis Quality Improvement Intervention
The 'before intervention' group collects data only before the training. \*This arm will receive the educational intervention after data collection is completed.
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.
Number 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
Time frame: up to 30 days
Feasibility of recruitment of clusters (hospitals) in this study design
Measured by the number of participating hospitals and countries
Time frame: Through to study completion, expected 1 year
Time to site set-up in this study design
Time taken for study set-up at sites from registration to randomisation
Time frame: Through to study completion, expected 1 year
Uptake of online educational modules
The proportion of eligible surgeons to undertake the educational modules in participating units.
Time frame: Through to study completion, expected 1 year
Understanding uptake and effectiveness of online educational modules
Semi-structured interviews will be undertaken at purposefully sampled units to assess longevity of the intervention
Time frame: Surgeons will have 30 days to complete the educational evaluation to collect CPD (continuing professional development) certificate. Interviews will take place 3-6 months after study completion at individual units.
Adherence to implementation of the Safe Anastomosis Programme
The proportion of eligible patients whose team completed the pre-operative risk stratification and Safe Anastomosis Checklist
Time frame: day of index operation
Plan to share: Yes — The investigators anticipate that the study protocol will be published early 2020. The Clinical Study report will be published most likely in 2021. This study will not collect patient identifiable data. All 'individual participant data' will be anonymised.
Supporting information: Study protocol, Sap
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University of Birmingham