2019 Safe-anastomosis Programme in Colorectal Surgery

Trial Overview

Acronym	EAGLE
Number	NCT04270721
Protocol Link	https://www.escp.eu.com/images/research/documents/ESCP-2019-EAGLE-Protocol-v0.21-2019-09-18.pdf
Status	In Follow-Up
Category	Proctology
Treatment Course	Surgery

Trial Description

The ESCP Safe-anastomosis Programme in Colorectal Surgery (EAGLE) is an international, multi-centre, cluster randomised-sequence service improvement study of the ESCP Safe-anastomosis Quality Improvement Intervention to reduce anastomotic leak following right colectomy and ileocaecal resection. Any hospital or surgical unit performing elective and/or emergency colorectal surgery may participate. The study consists of interactive, online training modules for surgeons and theatre teams and will

Chief Investigator

Dion Morton
Professor

Profile Link

Lead Centre

University of Birmingham
Institute of Cancer and Genomic Sciences
Birmingham
B15 2TH
United Kingdom

Website

Additional Information

Full Research Summary

Objective:	To determine whether a quality improvement intervention (QII) leads to a clinically-relevant overall reduction in anastomotic leak rate from 8.1 to 5.6% (relative reduction 30%) following right colectomy.
Aim:	To assess whether implementation of the European Society of Coloproctology (ESCP) Safe anastomosis Intervention reduces risk of anastomotic leak up to 30-days following right colectomy.
Methods:	EAGLE is an international, multicentre, cluster-sequence randomised controlled study evaluating the impact of implementation of the ESCP Safe-anastomosis Intervention on anastomotic leak rates following right colectomy. The intervention will be delivered at hospital-level so randomisation will be by hospital, with outcomes assessed at the individual patient level. To ensure that the study is attractive for potential collaborators to participate, all hospitals will implement the quality improvement programme, including those randomised to only collect pre-intervention data. To prevent baseline data gradually becoming contaminated by prior knowledge of the intervention or other unrelated background changes in patient care, we aim to complete data collection within 12 months.
Reason for International Trial:	When patients undergo bowel surgery, for example for a polyp, bowel cancer or inflammatory bowel disease, a section of the bowel is removed. In most patients the ends of the bowel are then joined back together; this is what surgeons call a bowel ‘anastomosis’. Although by this stage of the operation the disease has already been removed, the quality of this join is critical to the outcome of surgery. The most feared complication after surgery by both surgeons and patients alike is a leak from this join (an ‘anastomotic leak’).