ESCP Safe Anastomosis proGramme in coLorectal surgEry

Anastomotic Leak Clinical Trial

— EAGLE  

Official title:

ESCP Safe Anastomosis proGramme in coLorectal surgEry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04270721
• Other study ID #: RG_19196
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2021
• Source: University of Birmingham
• Contact: James Keatley
• Phone: +44 (0)121 371 8026
• Email: J.Keatley[@]bham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4400
• Est. completion date: July 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anastomosis; Complications
• Anastomotic Leak

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.

Locations

Country	Name	City	State
Russian Federation	Clinic of Coloproctology and Minimally Invasive Surgery	Moscow

Sponsors (3)

Lead Sponsor	Collaborator
University of Birmingham	Ethicon, Inc., European Society of Coloproctology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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.
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Length of hospital stay following right hemicolectomy or ileocaecal resection	Measured in post-operative days	up to 30 days