Anastomotic LeakEAGLENCT04270721
ESCP Safe Anastomosis proGramme in coLorectal surgEry
A study testing The EAGLE Safe Anastomosis Quality Improvement Intervention in people with Anastomotic Leak and Anastomosis; Complications, run by University of Birmingham at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak, Anastomosis; Complications
- What is being tested?
- The EAGLE Safe Anastomosis Quality Improvement Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,400 participants
- Where
- 1 siteRussia
- Study dates
- 3 Feb 2020to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Clinic of Coloproctology and Minimally Invasive Surgery
Moscow
Tatiana Gormanova
About this study
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.
Read the 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.
- Conditions
- Anastomotic Leak, Anastomosis; Complications
- Being tested
- The EAGLE Safe Anastomosis Quality Improvement Intervention
- Keywords
- anastomotic leak, right colectomy, cluster randomised study, leak prediction
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The EAGLE Safe Anastomosis Quality Improvement InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| After intervention (sequence 1) | Experimental | 'After intervention' group receives the training immediately and data are only collected after the intervention. Receives: Behavioral: The EAGLE Safe Anastomosis Quality Improvement Intervention |
| Before and after intervention (sequence 2) | Experimental | For the 'Before and after intervention' group, data are collected both before and after the training. Receives: Behavioral: The EAGLE Safe Anastomosis Quality Improvement Intervention |
| Before intervention (sequence 3) | No intervention | The 'before intervention' group collects data only before the training. *This arm will receive the educational intervention after data collection is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 30 days from operation
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: At index operation
Length of hospital stay following right hemicolectomy or ileocaecal resection
Measured in post-operative days
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start3 Feb 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anastomotic LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc., European Society of Coloproctology
- Responsible party
- Sponsor
- Investigators
- Dion Morton, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270721
- Sponsor's protocol ID
- RG_19196
- Acronym
- EAGLE
- Status last verified
- Sep 2021
- First submitted
- 12 Dec 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
ESCP EAGLE Safe Anastomosis Collaborative and NIHR Global Health Research Unit in Surgery. Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries. Br J Surg. 2024 Jan 3;111(1):znad370. doi: 10.1093/bjs/znad370.
PubMed 38029386Venn ML, Knowles CH, Li E, Glasbey J, Morton DG, Hooper R; ESCP EAGLE Safe Anastomosis Collaborative. Implementation of a batched stepped wedge trial evaluating a quality improvement intervention for surgical teams to reduce anastomotic leak after right colectomy. Trials. 2023 May 15;24(1):329. doi: 10.1186/s13063-023-07318-9.
PubMed 37189166ESCP 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.
PubMed 34255417
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESCP Safe Anastomosis proGramme in coLorectal surgEry
- ClinicalTrials.gov ID
- NCT04270721
- Acronym / sponsor ID
- EAGLE / RG_19196
- Conditions
- Anastomotic Leak, Anastomosis; Complications
- Keywords
- anastomotic leak, right colectomy, cluster randomised study, leak prediction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,400 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Ethicon, Inc., European Society of Coloproctology
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| After intervention (sequence 1) | Experimental | Behavioral: The EAGLE Safe Anastomosis Quality Improvement Intervention'After intervention' group receives the training immediately and data are only collected after the intervention. |
| Before and after intervention (sequence 2) | Experimental | Behavioral: The EAGLE Safe Anastomosis Quality Improvement InterventionFor the 'Before and after intervention' group, data are collected both before and after the training. |
| Before intervention (sequence 3) | No intervention | –The 'before intervention' group collects data only before the training. *This arm will receive the educational intervention after data collection is completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The EAGLE Safe Anastomosis Quality Improvement InterventionThe 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: 1. Introduction of a routine patient risk stratification for anastomotic leak 2. Implementation of the ESCP Safe Anastomosis Checklist 3. Adoption of a harmonised technique for stapled and handsewn anastomosis based on best evidence. | Behavioural | After intervention (sequence 1), Before and after intervention (sequence 2) |
Primary outcome
Number of patients diagnosed clinically or radiologically with anastomotic leak within 30 days of surgery
Time frame: 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).
4 secondary outcomes
The rate of re-operation for anastomotic leak
Time frame: up to 30 days
The rate of adverse outcomes following right hemicolectomy or ileocaecal resection
Time frame: up to 30 days
The rate of stoma formation
Time frame: At index operation
Length of hospital stay following right hemicolectomy or ileocaecal resection
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 38029386ESCP EAGLE Safe Anastomosis Collaborative and NIHR Global Health Research Unit in Surgery. Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries. Br J Surg. 2024 Jan 3;111(1):znad370. doi: 10.1093/bjs/znad370.
- Derived from this study: PubMed 37189166Venn ML, Knowles CH, Li E, Glasbey J, Morton DG, Hooper R; ESCP EAGLE Safe Anastomosis Collaborative. Implementation of a batched stepped wedge trial evaluating a quality improvement intervention for surgical teams to reduce anastomotic leak after right colectomy. Trials. 2023 May 15;24(1):329. doi: 10.1186/s13063-023-07318-9.
- Derived from this study: PubMed 34255417ESCP 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dion Morton principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The EAGLE Safe Anastomosis Quality Improvement Intervention in people with Anastomotic Leak and Anastomosis; Complications, run by University of Birmingham at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Keatley (+44 (0)121 371 8026, J.Keatley@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients diagnosed clinically or radiologically with anastomotic leak within 30 days of surgery (time frame: up to 30 days from operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04270721, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.