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

ESCP EAGLE Safe Anastomosis Collaborative; Dion Morton

doi:10.1111/codi.15806

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

ESCP EAGLE Safe Anastomosis Collaborative, Dion Morton

Applied Health Research

Research output: Contribution to journal › Article › peer-review

63 Downloads (Pure)

Abstract

AIM: Cohort data suggest that anastomotic leak occurs after 8% of right colectomies causing significant morbidity and mortality. Patient selection, intra-operative factors, and technical variation all contribute to risk of leak. The EAGLE study will assess whether implementation of the European Society of Coloproctology (ESCP) Safe Anastomosis Intervention reduces anastomotic leak following right colectomy.

METHODS: An international, multi-centre, cluster randomised trial will be undertaken with hospitals as clusters. Hospitals will be recruited in a number of distinct phases, with each phase following the same research plan, in which clusters are randomised to one of three, staggered (dog-leg) schedules for implementation of the Safe Anastomosis Intervention.

RESULTS: Results from different phases will be meta-analysed. The intervention is a three-component behavioural change programme for surgeons, anaesthetists and operating room staff, supported by an online learning environment. All colorectal surgical units around the world will be eligible. Adults undergoing elective or emergency right colectomy or ileocaecal resection, by any approach and for any indication will be included. The primary outcome is 30-day anastomotic leak rate, defined as clinical or radiologically-detected leak or intra-abdominal or pelvic collection. Assuming hospitals provide data for an average of 10 patients per two month recruitment period, 333 clusters (4440 patients in total) will allow for detection of an absolute risk reduction of anastomotic leak from 8.1% to 5.6% (relative risk reduction 30%). This protocol adheres to Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT).

DISCUSSION: The protocol describes the methods for an evaluation of a hospital-level, education-based quality improvement intervention targeted to reduce the life-threatening surgical complication of anastomotic leak.

Original language	English
Pages (from-to)	2761-2771
Number of pages	11
Journal	Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland
Volume	23
Issue number	10
Early online date	13 Jul 2021
DOIs	https://doi.org/10.1111/codi.15806
Publication status	Published - 25 Oct 2021

Bibliographical note

Keywords

Anastomosis, Surgical/adverse effects
Anastomotic Leak/etiology
Animals
Colectomy/adverse effects
Colorectal Surgery/adverse effects
Dogs
Humans
Quality Improvement
Randomized Controlled Trials as Topic

Access to Document

10.1111/codi.15806Licence: None: All rights reserved

ESCP Safe Anastomosis ProGramme in CoLorectal SurgEry (EAGLE)- Study protocol for an international cluster randomised trial of a quality improvement intervention
This is the peer reviewed version of the following article: ESCP Safe Anastomosis ProGramme in CoLorectal SurgEry (EAGLE). Colorectal Dis. 2021; 23: 2761– 2771, which has been published in final form at https://doi.org/10.1111/codi.15806. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. This article may not be enhanced, enriched or otherwise transformed into a derivative work, without express permission from Wiley or by statutory rights under applicable legislation. Copyright notices must not be removed, obscured or modified. The article must be linked to Wiley’s version of record on Wiley Online Library and any embedding, framing or otherwise making available the article or pages thereof by third parties from platforms, services and websites other than Wiley Online Library must be prohibited.
Accepted author manuscript, 620 KBLicence: Other (please specify with Rights Statement)

https://qmro.qmul.ac.uk/xmlui/handle/123456789/73140Licence: Other (please specify with Rights Statement)

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this

ESCP EAGLE Safe Anastomosis Collaborative, & Morton, D. (2021). 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 disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 23(10), 2761-2771. https://doi.org/10.1111/codi.15806

ESCP EAGLE Safe Anastomosis Collaborative ; Morton, Dion. / 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. In: Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland. 2021 ; Vol. 23, No. 10. pp. 2761-2771.

@article{5ef0ee04fd004bfeb0d412fd8892114a,

title = "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",

abstract = "AIM: Cohort data suggest that anastomotic leak occurs after 8% of right colectomies causing significant morbidity and mortality. Patient selection, intra-operative factors, and technical variation all contribute to risk of leak. The EAGLE study will assess whether implementation of the European Society of Coloproctology (ESCP) Safe Anastomosis Intervention reduces anastomotic leak following right colectomy.METHODS: An international, multi-centre, cluster randomised trial will be undertaken with hospitals as clusters. Hospitals will be recruited in a number of distinct phases, with each phase following the same research plan, in which clusters are randomised to one of three, staggered (dog-leg) schedules for implementation of the Safe Anastomosis Intervention.RESULTS: Results from different phases will be meta-analysed. The intervention is a three-component behavioural change programme for surgeons, anaesthetists and operating room staff, supported by an online learning environment. All colorectal surgical units around the world will be eligible. Adults undergoing elective or emergency right colectomy or ileocaecal resection, by any approach and for any indication will be included. The primary outcome is 30-day anastomotic leak rate, defined as clinical or radiologically-detected leak or intra-abdominal or pelvic collection. Assuming hospitals provide data for an average of 10 patients per two month recruitment period, 333 clusters (4440 patients in total) will allow for detection of an absolute risk reduction of anastomotic leak from 8.1% to 5.6% (relative risk reduction 30%). This protocol adheres to Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT).DISCUSSION: The protocol describes the methods for an evaluation of a hospital-level, education-based quality improvement intervention targeted to reduce the life-threatening surgical complication of anastomotic leak.",

keywords = "Anastomosis, Surgical/adverse effects, Anastomotic Leak/etiology, Animals, Colectomy/adverse effects, Colorectal Surgery/adverse effects, Dogs, Humans, Quality Improvement, Randomized Controlled Trials as Topic",

author = "{ESCP EAGLE Safe Anastomosis Collaborative} and Dion Morton",

note = "{\textcopyright} 2021 The Association of Coloproctology of Great Britain and Ireland.",

year = "2021",

month = oct,

day = "25",

doi = "10.1111/codi.15806",

language = "English",

volume = "23",

pages = "2761--2771",

journal = "Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland",

issn = "1462-8910",

publisher = "Wiley",

number = "10",

}

ESCP EAGLE Safe Anastomosis Collaborative & Morton, D 2021, '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 disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, vol. 23, no. 10, pp. 2761-2771. https://doi.org/10.1111/codi.15806

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. / ESCP EAGLE Safe Anastomosis Collaborative ; Morton, Dion.
In: Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, Vol. 23, No. 10, 25.10.2021, p. 2761-2771.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - ESCP Safe Anastomosis ProGramme in CoLorectal SurgEry (EAGLE)

T2 - Study protocol for an international cluster randomised trial of a quality improvement intervention to reduce anastomotic leak following right colectomy

AU - ESCP EAGLE Safe Anastomosis Collaborative

AU - Morton, Dion

PY - 2021/10/25

Y1 - 2021/10/25

N2 - AIM: Cohort data suggest that anastomotic leak occurs after 8% of right colectomies causing significant morbidity and mortality. Patient selection, intra-operative factors, and technical variation all contribute to risk of leak. The EAGLE study will assess whether implementation of the European Society of Coloproctology (ESCP) Safe Anastomosis Intervention reduces anastomotic leak following right colectomy.METHODS: An international, multi-centre, cluster randomised trial will be undertaken with hospitals as clusters. Hospitals will be recruited in a number of distinct phases, with each phase following the same research plan, in which clusters are randomised to one of three, staggered (dog-leg) schedules for implementation of the Safe Anastomosis Intervention.RESULTS: Results from different phases will be meta-analysed. The intervention is a three-component behavioural change programme for surgeons, anaesthetists and operating room staff, supported by an online learning environment. All colorectal surgical units around the world will be eligible. Adults undergoing elective or emergency right colectomy or ileocaecal resection, by any approach and for any indication will be included. The primary outcome is 30-day anastomotic leak rate, defined as clinical or radiologically-detected leak or intra-abdominal or pelvic collection. Assuming hospitals provide data for an average of 10 patients per two month recruitment period, 333 clusters (4440 patients in total) will allow for detection of an absolute risk reduction of anastomotic leak from 8.1% to 5.6% (relative risk reduction 30%). This protocol adheres to Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT).DISCUSSION: The protocol describes the methods for an evaluation of a hospital-level, education-based quality improvement intervention targeted to reduce the life-threatening surgical complication of anastomotic leak.

AB - AIM: Cohort data suggest that anastomotic leak occurs after 8% of right colectomies causing significant morbidity and mortality. Patient selection, intra-operative factors, and technical variation all contribute to risk of leak. The EAGLE study will assess whether implementation of the European Society of Coloproctology (ESCP) Safe Anastomosis Intervention reduces anastomotic leak following right colectomy.METHODS: An international, multi-centre, cluster randomised trial will be undertaken with hospitals as clusters. Hospitals will be recruited in a number of distinct phases, with each phase following the same research plan, in which clusters are randomised to one of three, staggered (dog-leg) schedules for implementation of the Safe Anastomosis Intervention.RESULTS: Results from different phases will be meta-analysed. The intervention is a three-component behavioural change programme for surgeons, anaesthetists and operating room staff, supported by an online learning environment. All colorectal surgical units around the world will be eligible. Adults undergoing elective or emergency right colectomy or ileocaecal resection, by any approach and for any indication will be included. The primary outcome is 30-day anastomotic leak rate, defined as clinical or radiologically-detected leak or intra-abdominal or pelvic collection. Assuming hospitals provide data for an average of 10 patients per two month recruitment period, 333 clusters (4440 patients in total) will allow for detection of an absolute risk reduction of anastomotic leak from 8.1% to 5.6% (relative risk reduction 30%). This protocol adheres to Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT).DISCUSSION: The protocol describes the methods for an evaluation of a hospital-level, education-based quality improvement intervention targeted to reduce the life-threatening surgical complication of anastomotic leak.

KW - Anastomosis, Surgical/adverse effects

KW - Anastomotic Leak/etiology

KW - Animals

KW - Colectomy/adverse effects

KW - Colorectal Surgery/adverse effects

KW - Dogs

KW - Humans

KW - Quality Improvement

KW - Randomized Controlled Trials as Topic

U2 - 10.1111/codi.15806

DO - 10.1111/codi.15806

M3 - Article

C2 - 34255417

SN - 1462-8910

VL - 23

SP - 2761

EP - 2771

JO - Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland

JF - Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland

IS - 10

ER -

ESCP EAGLE Safe Anastomosis Collaborative, Morton D. 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 disease : the official journal of the Association of Coloproctology of Great Britain and Ireland. 2021 Oct 25;23(10):2761-2771. Epub 2021 Jul 13. doi: 10.1111/codi.15806