ESCP Safe Anastomosis proGramme in coLorectal surgEry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

4400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2022-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anastomotic Leak Anastomosis; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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).

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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After intervention (sequence 1)

'After intervention' group receives the training immediately and data are only collected after the intervention.

Group Type EXPERIMENTAL

The EAGLE Safe Anastomosis Quality Improvement Intervention

Intervention Type BEHAVIORAL

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.

Before and after intervention (sequence 2)

For the 'Before and after intervention' group, data are collected both before and after the training.

Group Type EXPERIMENTAL

The EAGLE Safe Anastomosis Quality Improvement Intervention

Intervention Type BEHAVIORAL

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.

Before intervention (sequence 3)

The 'before intervention' group collects data only before the training.

\*This arm will receive the educational intervention after data collection is completed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No