Anastomotic Leak Clinical Trial
— EAGLEOfficial title:
ESCP Safe Anastomosis proGramme in coLorectal surgEry
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Clinic of Coloproctology and Minimally Invasive Surgery | Moscow |
Lead Sponsor | Collaborator |
---|---|
University of Birmingham | Ethicon, Inc., European Society of Coloproctology |
Russian Federation,
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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