NCT04270721

ESCP Safe Anastomosis proGramme in coLorectal surgEry

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,400 (estimated)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anastomotic Leak
• Anastomosis; Complications

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2020-02-03
• Primary completion: 2021-12-31
• Completion: 2022-07-01
• First posted: 2020-02-17
• Last updated: 2021-09-29

Locations

1 site across 1 country: Russia