ESCP Safe Anastomosis proGramme in coLorectal surgEry

Not Applicable

• Conditions: Anastomotic Leak; Anastomosis; Complications

• Registration Number: NCT04270721
• Lead Sponsor: University of Birmingham

Brief 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.

Study Timeline

• Study First Submitted: 2019-12-12
• Study Start: 2020-02-03
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29
• Primary Completion: 2021-12-31
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Number of patients diagnosed clinically or radiologically with anastomotic leak within 30 days of surgery	up to 30 days from operation	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).

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay following right hemicolectomy or ileocaecal resection	up to 30 days	Measured in post-operative days
The rate of re-operation for anastomotic leak	up to 30 days	The number of patients re-operated, of those diagnosed with anastomotic leak following right hemicolectomy or ileocaecal resection
The rate of adverse outcomes following right hemicolectomy or ileocaecal resection	up to 30 days	For all patients included in the study (i.e. who underwent right hemicolectomy or ileocaecal resection whether or not with primary anastomosis); 1. Number of patients undergoing re-operation for any cause within 30 days; 2. Number of patients with unplanned admission to critical care within 30 days; 3. Number of patients re-admitted to hospital within 30 days; 4. Mortality rate within 30 days
The rate of stoma formation	At index operation	For all patients included in the study (i.e. who underwent right hemicolectomy or ileocaecal resection whether or not with primary anastomosis); 1. Rate of formation of ileostomy without primary anastomosis; 2. Rate of defunctioning ileostomy with primary anastomosis

Trial Locations

Locations (1)

Clinic of Coloproctology and Minimally Invasive Surgery; 🇷🇺 Moscow, Russian Federation