Anastomosis; Complications, Anastomotic Leak
Conditions
Keywords
anastomotic leak, right colectomy, cluster randomised study, leak prediction
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALThe EAGLE Safe Anastomosis Quality Improvement Intervention
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.
Sponsors
Ethicon, Inc.
European Society of Coloproctology
University of Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
EAGLE is an international, multicentre, cluster-sequence randomised controlled study. The intervention will be delivered at hospital-level so randomisation will be by hospital, with outcomes assessed at the individual patient level. Cluster randomisation will follow a dog-leg phased study design with 3 randomisation sequences. In the first phase, approximately 48 hospitals (clusters) are randomised between the three sequences, all three are eventually exposed to the intervention. Sequence 1 immediately receives the training intervention and data are only collected after the intervention. In sequence 2, data are collected before and after the intervention. The final sequence collects data only before the intervention. The second dogleg phase commences after the first when more clusters are ready to participate (indicatively after one month, but can be delayed as practicable). Indicatively, 7 dogleg phases with 48 hospitals each, will achieve the sample size required (333 clusters).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients diagnosed clinically or radiologically with anastomotic leak within 30 days of surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of re-operation for anastomotic leak | up to 30 days | The number of patients re-operated, of those diagnosed with anastomotic leak following right hemicolectomy or ileocaecal resection |
| The rate of adverse outcomes following right hemicolectomy or ileocaecal resection | up to 30 days | 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 |
| The rate of stoma formation | At index operation | 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 |
| Length of hospital stay following right hemicolectomy or ileocaecal resection | up to 30 days | Measured in post-operative days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of recruitment of clusters (hospitals) in this study design | Through to study completion, expected 1 year | Measured by the number of participating hospitals and countries |
| Time to site set-up in this study design | Through to study completion, expected 1 year | Time taken for study set-up at sites from registration to randomisation |
| Uptake of online educational modules | Through to study completion, expected 1 year | The proportion of eligible surgeons to undertake the educational modules in participating units. |
| Understanding uptake and effectiveness of online educational modules | 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. | Semi-structured interviews will be undertaken at purposefully sampled units to assess longevity of the intervention |
| Adherence to implementation of the Safe Anastomosis Programme | day of index operation | The proportion of eligible patients whose team completed the pre-operative risk stratification and Safe Anastomosis Checklist |
Countries
Russia
Contacts
Primary ContactJames Keatley
Backup ContactBrett Dawson
Outcome results
None listed