ESCP Safe Anastomosis proGramme in coLorectal surgEry (EAGLE)

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.

Study Overview

• Status: Recruiting
• Conditions: Anastomotic Leak; Anastomosis; Complications
• Intervention / Treatment: Behavioral: The EAGLE Safe Anastomosis Quality Improvement Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 4400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James Keatley; Phone Number: +44 (0)121 371 8026; Email: J.Keatley@bham.ac.uk
• Study Contact Backup: Name: Brett Dawson; Phone Number: +44 (0) 121 371 8140; Email: B.Dawson@bham.ac.uk

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • Clinic of coloproctology and minimally invasive surgery
    • Contact: Tatiana Gormanova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: After intervention (sequence 1); 'After intervention' group receives the training immediately and data are only collected after the intervention.	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: Introduction of a routine patient risk stratification for anastomotic leak; Implementation of the ESCP Safe Anastomosis Checklist; Adoption of a harmonised technique for stapled and handsewn anastomosis based on best evidence.
Experimental: Before and after intervention (sequence 2); 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 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: Introduction of a routine patient risk stratification for anastomotic leak; Implementation of the ESCP Safe Anastomosis Checklist; Adoption of a harmonised technique for stapled and handsewn anastomosis based on best evidence.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	up to 30 days from operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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); Number of patients undergoing re-operation for any cause within 30 days; Number of patients with unplanned admission to critical care within 30 days; Number of patients re-admitted to hospital within 30 days; Mortality rate within 30 days	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); Rate of formation of ileostomy without primary anastomosis; Rate of defunctioning ileostomy with primary anastomosis	At index operation
Length of hospital stay following right hemicolectomy or ileocaecal resection	Measured in post-operative days	up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment of clusters (hospitals) in this study design	Measured by the number of participating hospitals and countries	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	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.	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	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	day of index operation

Collaborators and Investigators

• Sponsor: University of Birmingham
• Collaborators: Ethicon, Inc.; European Society of Coloproctology
• Investigators: Principal Investigator: Dion Morton, University of Birmingham

Publications and helpful links

General Publications

• ESCP EAGLE Safe Anastomosis Collaborative. ESCP Safe Anastomosis ProGramme in CoLorectal SurgEry (EAGLE): Study protocol for an international cluster randomised trial of a quality improvement intervention to reduce anastomotic leak following right colectomy. Colorectal Dis. 2021 Oct;23(10):2761-2771. doi: 10.1111/codi.15806. Epub 2021 Aug 25.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: anastomotic leak; right colectomy; cluster randomised study; leak prediction
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak
• Other Study ID Numbers: RG_19196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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.

• IPD Sharing Time Frame: Data will be available beginning 6 months and ending 36 months after the primary study analysis has been published.

IPD Sharing Access Criteria

Data will be available to researchers submitting a methodologically sound proposal. Proposals should be directed to Dion.Morton@uhb.nhs.uk. To gain access requestors will need to sign a data access agreement.

After 36 months the data will be available but without investigator support other than deposited metadata.

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No