UMIN-CTR Clinical Trial

Basic information
Public title	An international, cluster randomised-sequence study of a safe-anastomosis quality improvement intervention to reduce anastomotic leak following right colectomy and ileocaecal resection
Acronym	EAGLE
Scientific Title	An international, cluster randomised-sequence study of a safe-anastomosis quality improvement intervention to reduce anastomotic leak following right colectomy and ileocaecal resection
Scientific Title:Acronym	EAGLE
Region	Japan Asia(except Japan) North America South America Australia Europe Africa

Condition
Condition	All adult patients (age 18 years and above) undergoing right colectomy with or without primary anastomosis
Classification by specialty	Surgery in general Gastrointestinal surgery Anesthesiology Operative medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Anastomotic leak rate following right colectomy at 30-days after surgery
Key secondary outcomes	Clinical outcomes within 30-days of surgery including: a. Reoperation for anastomotic leak b. Reoperation for any cause c. Unplanned admission to critical care d. Readmission to hospital e. Postoperative mortality f. Length of hospital stay

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	ESCP Safe Anastomosis quality improvement intervention
Interventions/Control_2	Pre-intervention data will act as control data
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	Inclusion criteria Adults >=18 years of age. Right colectomy, defined as any colonic transection with the distal resection margin proximal to the splenic flexure. Procedures for any pathology (benign or malignant), via any operative approach (open, laparoscopic, robotic or converted). Patients undergoing elective (during a planned admission), expedited or emergency surgery (during an unplanned admission). Patients undergoing colectomy and a synchronous procedure on a different organ e.g. hepatic metastatectomy.
Key exclusion criteria	Exclusion criteria Patients undergoing more than one gastrointestinal anastomosis during the index operation. In Crohn's disease, additional upstream strictureplasty or resection/anastomosis to treat disease or strictures at the same operation. Patients undergoing concurrent hyperthermic intraperitoneal chemotherapy (HIPEC) and/or cytoreductive surgery. Individual patients should only be included in EAGLE once. Following the index EAGLE study procedure, patients undergoing further operative treatment within the study window should not have repeated entries created.
Target sample size	4400

Research contact person
Name of lead principal investigator	1st name Akihiko Middle name Last name Horiguchi
Organization	Fujita Health University Bantane Hospital
Division name	Department of Gastroenterological Surgery
Zip code	454-8509
Address	3-6-10 Otoubashi, Nakagawa-ku, Nagoya City, Aichi, 454-8509, Japan
TEL	052-321-8171
Email	akihori@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Akihiko Middle name Last name Horiguchi
Organization	Fujita Health University Bantane Hospital
Division name	Department of Gastroenterological Surgery
Zip code	454-8509
Address	3-6-10 Otoubashi, Nakagawa-ku, Nagoya City, Aichi, 454-8509, Japan
TEL	052-321-8171
Homepage URL
Email	akihori@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	University of Birmingham
Name of secondary funder(s)	the European Society of Coloproctology (ESCP)

IRB Contact (For public release)
Organization	Fujita Health University Bantane Hospital
Address	3-6-10 Otoubashi, Nakagawa-ku, Nagoya City, Aichi, 454-8509, Japan
Tel	052-321-8171
Email	akihori@fujita-hu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 09 Month 21 Day
Date of IRB	2021 Year 10 Month 25 Day
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 09 Month 21 Day
Last modified on	2022 Year 11 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051986