Status:

UNKNOWN

ESCP Safe Anastomosis proGramme in coLorectal surgEry

Lead Sponsor:

University of Birmingham

Collaborating Sponsors:

Ethicon, Inc.

European Society of Coloproctology

Conditions:

Anastomotic Leak

Anastomosis; Complications

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

EAGLE is an international service improvement study to investigate the value of an educational tool delivered to surgeons and their teams to reduce the risk of anastomotic leak (leak of a join in the ...

Detailed Description

EAGLE is an international quality improvement programme to share best practice and harmonise ileo-colic anastomosis procedures through an education programme for surgeons and theatre teams. The progr...

Eligibility Criteria

Inclusion

  • All adult patients (age 18 years and above) undergoing right colectomy with or without primary anastomosis. Right colectomy is defined as ileocaecal resection or right hemicolectomy (any colonic transection with the distal resection margin proximal to the splenic flexure).
  • All patients undergoing right colectomy are eligible, including those who do not have an anastomosis and are defunctioned by a proximal stoma.
  • Procedures for any pathology, via any operative approach (open, laparoscopic, robotic or converted) are eligible.
  • Elective (surgery on a planned admission), expedited, and emergency (surgery on an unplanned admission) procedures are eligible.

Exclusion

  • Patients undergoing more than one gastrointestinal anastomosis during the same operation.
  • In Crohn's disease, additional upstream stricturoplasty or resection/anastomosis to treat disease or strictures at the same operation.
  • Simultaneous right colectomy and hyperthermic intraperitoneal chemotherapy (HIPEC) and/or cytoreductive surgery.
  • Each individual patient should only be included in EAGLE once. Following the index procedure that is included in EAGLE, patients undergoing additional procedures within the study window should not be included for a second time.

Key Trial Info

Start Date :

February 3 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2022

Estimated Enrollment :

4400 Patients enrolled

Trial Details

Trial ID

NCT04270721

Start Date

February 3 2020

End Date

July 1 2022

Last Update

September 29 2021

Active Locations (1)

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Clinic of Coloproctology and Minimally Invasive Surgery

Moscow, Russia