EAGLE
Trial question
What is the role of the European Society of Coloproctology Safe Anastomosis Program in Colorectal Surgery (EAGLE) quality improvement intervention in reducing anastomotic leak after right colectomy?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
48.0% female
52.0% male
N = 3268
3268 patients (1579 female, 1689 male).
Inclusion criteria: surgical teams performing right colectomy for any indication or urgency.
Key exclusion criteria: multiple anastomoses; distal resection margin beyond splenic flexture; undergoing additional synchronous procedures; undergoing second eligible operation.
Interventions
N=1827 EAGLE program (surgery by surgical teams exposed to the EAGLE Safe Anastomosis program).
N=1441 standard care (surgery by surgical teams before the implementation of the EAGLE Safe Anastomosis program).
Primary outcome
Anastomotic leak rate
9.6%
10.1%
10.1 %
7.6 %
5.0 %
2.5 %
0.0 %
EAGLE
program
Standard
care
No significant
difference ↔
No significant difference in anastomotic leak rate (9.6% vs. 10.1%; OR 0.87, 95% CI 0.59 to 1.3).
Secondary outcomes
No significant difference in clinical leak rate (4.5% vs. 5.6%; OR 0.77, 95% CI 0.53 to 1.12).
No significant difference in death (4% vs. 4.2%; OR 1.02, 95% CI 0.7 to 1.49).
No significant difference in reoperation (7% vs. 7.5%; OR 0.94, 95% CI 0.7 to 1.26).
Conclusion
In surgical teams performing right colectomy for any indication or urgency, EAGLE program was not superior to standard care with respect to anastomotic leak rate.
Reference
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.
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