ESCP Safe Anastomosis proGramme in coLorectal surgEry (EAGLE)

University of Birmingham

Status: Unknown

Conditions: Anastomosis; Complications; Anastomotic Leak

Treatments: Behavioral: The EAGLE Safe Anastomosis Quality Improvement Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04270721

RG_19196

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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4,400 participants in 3 patient groups

After intervention (sequence 1)

Experimental group

Description:

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

Treatment:

Behavioral: The EAGLE Safe Anastomosis Quality Improvement Intervention

Before and after intervention (sequence 2)

Experimental group

Description:

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

Treatment:

Behavioral: The EAGLE Safe Anastomosis Quality Improvement Intervention

Before intervention (sequence 3)

No Intervention group

Description:

The 'before intervention' group collects data only before the training. \*This arm will receive the educational intervention after data collection is completed.