Clinical trial NCT04270721: ESCP Safe Anastomosis proGramme in coLorectal surgEry
Official title: ESCP Safe Anastomosis proGramme in coLorectal surgEry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anastomotic Leak
Anastomosis; Complications
Keywords: anastomotic leak
right colectomy
cluster randomised study
leak prediction
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
name: European Society of Coloproctology
First posted: 2020-02-17
Enrollment: 4400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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).
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of patients diagnosed clinically or radiologically with anastomotic leak within 30 days of surgery
timeFrame: up to 30 days from operation
Secondary outcomes:
measure: The rate of re-operation for anastomotic leak
timeFrame: up to 30 days
measure: The rate of adverse outcomes following right hemicolectomy or ileocaecal resection
timeFrame: up to 30 days
measure: The rate of stoma formation
timeFrame: At index operation
measure: Length of hospital stay following right hemicolectomy or ileocaecal resection
timeFrame: up to 30 days
Other outcomes:
measure: Feasibility of recruitment of clusters (hospitals) in this study design
timeFrame: Through to study completion, expected 1 year
measure: Time to site set-up in this study design
timeFrame: Through to study completion, expected 1 year
measure: Uptake of online educational modules
timeFrame: Through to study completion, expected 1 year
measure: Understanding uptake and effectiveness of online educational modules
timeFrame: 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.
measure: Adherence to implementation of the Safe Anastomosis Programme
timeFrame: day of index operation
Locations:
city: Moscow
country: Russian Federation
facility: Clinic of Coloproctology and Minimally Invasive Surgery
Study officials:
affiliation: University of Birmingham
name: Dion Morton
role: PRINCIPAL_INVESTIGATOR
References:
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.