ESCP Safe Anastomosis proGramme in coLorectal surgEry

NCT04270721 | Unknown DMC

• 1 other identifier: RG_19196
• Study Type: interventional
• Target: 4,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Anastomotic Leak; Anastomosis; Complications

Keywords

anastomotic leak; right colectomy; cluster randomised study; leak prediction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The rate of re-operation for anastomotic leak

  up to 30 days

• The rate of adverse outcomes following right hemicolectomy or ileocaecal resection

  up to 30 days

• The rate of stoma formation

  At index operation

• Length of hospital stay following right hemicolectomy or ileocaecal resection

  up to 30 days

Other Outcomes (5)

• Feasibility of recruitment of clusters (hospitals) in this study design

  Through to study completion, expected 1 year

• Time to site set-up in this study design

  Through to study completion, expected 1 year

• Uptake of online educational modules

  Through to study completion, expected 1 year

Study Arms (3)

After intervention (sequence 1)

EXPERIMENTAL

'After intervention' group receives the training immediately and data are only collected after the intervention.

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.

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.

Interventions

The EAGLE Safe Anastomosis Quality Improvement Intervention BEHAVIORAL

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: 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.

After intervention (sequence 1); Before and after intervention (sequence 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Birmingham: lead
• Ethicon, Inc.: collaborator
• European Society of Coloproctology: collaborator

Study Sites (1)

Clinic of Coloproctology and Minimally Invasive Surgery

Moscow, Russia

RECRUITING

Related Publications (3)

• 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.

  PMID: 38029386 DERIVED

• Venn 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.

  PMID: 37189166 DERIVED

• 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.

  PMID: 34255417 DERIVED

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dion Morton

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Keatley

CONTACT

+44 (0)121 371 8026; J.Keatley@bham.ac.uk

Brett Dawson

CONTACT

+44 (0) 121 371 8140; B.Dawson@bham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: February 17, 2020
• Study Start: February 3, 2020
• Primary Completion: December 31, 2021
• Study Completion: July 1, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months and ending 36 months after the primary study analysis has been published.
• 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.

Locations

RU (1)