Back to resultsESCP Safe Anastomosis proGramme in coLorectal surgEry (EAGLE)
Primary Purpose
Anastomotic Leak, Anastomosis; Complications
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
The EAGLE Safe Anastomosis Quality Improvement Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Anastomotic Leak focused on measuring anastomotic leak, right colectomy, cluster randomised study, leak prediction
Eligibility Criteria
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.
Sites / Locations
- Clinic of Coloproctology and Minimally Invasive SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
After intervention (sequence 1)
Before and after intervention (sequence 2)
Before intervention (sequence 3)
Arm Description
'After intervention' group receives the training immediately and data are only collected after the intervention.
For the 'Before and after intervention' group, data are collected both before and after the training.
The 'before intervention' group collects data only before the training. *This arm will receive the educational intervention after data collection is completed.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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
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
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
Length of hospital stay following right hemicolectomy or ileocaecal resection
Measured in post-operative days
Full Information
NCT ID
NCT04270721
First Posted
December 12, 2019
Last Updated
September 28, 2021
Sponsor
University of Birmingham
Collaborators
Ethicon, Inc., European Society of Coloproctology
1. Study Identification
Unique Protocol Identification Number
NCT04270721
Brief Title
ESCP Safe Anastomosis proGramme in coLorectal surgEry
Acronym
EAGLE
Official Title
ESCP Safe Anastomosis proGramme in coLorectal surgEry
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Birmingham
Collaborators
Ethicon, Inc., European Society of Coloproctology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leak, Anastomosis; Complications
Keywords
anastomotic leak, right colectomy, cluster randomised study, leak prediction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
EAGLE is an international, multicentre, cluster-sequence randomised controlled study. The intervention will be delivered at hospital-level so randomisation will be by hospital, with outcomes assessed at the individual patient level.
Cluster randomisation will follow a dog-leg phased study design with 3 randomisation sequences. In the first phase, approximately 48 hospitals (clusters) are randomised between the three sequences, all three are eventually exposed to the intervention. Sequence 1 immediately receives the training intervention and data are only collected after the intervention. In sequence 2, data are collected before and after the intervention. The final sequence collects data only before the intervention. The second dogleg phase commences after the first when more clusters are ready to participate (indicatively after one month, but can be delayed as practicable). Indicatively, 7 dogleg phases with 48 hospitals each, will achieve the sample size required (333 clusters).
Masking
ParticipantOutcomes Assessor
Masking Description
The patient will be blinded to their hospital's randomised sequence allocation. Analysis will be performed blind to allocation sequence (and therefore before and after status) and after data have been cleaned and locked.
Allocation
Randomized
Enrollment
4400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
After intervention (sequence 1)
Arm Type
Experimental
Arm Description
'After intervention' group receives the training immediately and data are only collected after the intervention.
Arm Title
Before and after intervention (sequence 2)
Arm Type
Experimental
Arm Description
For the 'Before and after intervention' group, data are collected both before and after the training.
Arm Title
Before intervention (sequence 3)
Arm Type
No Intervention
Arm Description
The 'before intervention' group collects data only before the training.
*This arm will receive the educational intervention after data collection is completed.
Intervention Type
Behavioral
Intervention Name(s)
The EAGLE Safe Anastomosis Quality Improvement Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients diagnosed clinically or radiologically with anastomotic leak within 30 days of surgery
Description
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).
Time Frame
up to 30 days from operation
Secondary Outcome Measure Information:
Title
The rate of re-operation for anastomotic leak
Description
The number of patients re-operated, of those diagnosed with anastomotic leak following right hemicolectomy or ileocaecal resection
Time Frame
up to 30 days
Title
The rate of adverse outcomes following right hemicolectomy or ileocaecal resection
Description
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
Time Frame
up to 30 days
Title
The rate of stoma formation
Description
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
Time Frame
At index operation
Title
Length of hospital stay following right hemicolectomy or ileocaecal resection
Description
Measured in post-operative days
Time Frame
up to 30 days
Other Pre-specified Outcome Measures:
Title
Feasibility of recruitment of clusters (hospitals) in this study design
Description
Measured by the number of participating hospitals and countries
Time Frame
Through to study completion, expected 1 year
Title
Time to site set-up in this study design
Description
Time taken for study set-up at sites from registration to randomisation
Time Frame
Through to study completion, expected 1 year
Title
Uptake of online educational modules
Description
The proportion of eligible surgeons to undertake the educational modules in participating units.
Time Frame
Through to study completion, expected 1 year
Title
Understanding uptake and effectiveness of online educational modules
Description
Semi-structured interviews will be undertaken at purposefully sampled units to assess longevity of the intervention
Time Frame
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.
Title
Adherence to implementation of the Safe Anastomosis Programme
Description
The proportion of eligible patients whose team completed the pre-operative risk stratification and Safe Anastomosis Checklist
Time Frame
day of index operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Keatley
Phone
+44 (0)121 371 8026
Email
J.Keatley@bham.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Brett Dawson
Phone
+44 (0) 121 371 8140
Email
B.Dawson@bham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dion Morton
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of Coloproctology and Minimally Invasive Surgery
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Gormanova
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34255417
Citation
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.
Results Reference
derived
Learn more about this trial
ESCP Safe Anastomosis proGramme in coLorectal surgEry
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