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An international, cluster randomised-sequence study of a safe-anastomosis quality improvement intervention to reduce anastomotic leak following right colectomy and ileocaecal resection

An international, cluster randomised-sequence study of a safe-anastomosis quality improvement intervention to reduce anastomotic leak following right colectomy and ileocaecal resection - EAGLE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045533
Enrollment
4400
Registered
2021-11-01
Start date
2021-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All adult patients (age 18 years and above) undergoing right colectomy with or without primary anastomosis

Interventions

ESCP Safe Anastomosis quality improvement intervention Pre-intervention data will act as control data

Sponsors

Fujita Health University
Lead Sponsor
University of Birmingham
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Anastomotic leak rate following right colectomy at 30-days after surgery

Secondary

MeasureTime frame
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

Countries

Japan,Asia(except Japan),North America,South America,Australia,Europe,Africa

Contacts

Public ContactAkihiko Horiguchi

Fujita Health University Bantane Hospital Department of Gastroenterological Surgery

akihori@fujita-hu.ac.jp052-321-8171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026