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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04270721
Other study ID # RG_19196
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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