Application of ERAS Protocol in Emergency Surgery (ERAS in CDU)

This study defines a standardized protocol inspired to the ERAS philosophy for the peri-operative treatment of patients undergoing emergency abdominal surgery. Primary endpoint is the feasibility of the application of the standardized protocol; secondary endpoint is the safety

Study Overview

• Status: Completed
• Conditions: Enhanced Recovery After Surgery; Emergency Surgery
• Intervention / Treatment: Other: Application of ERAS protocol

• Study Type: Observational
• Enrollment (Actual): 589

Contacts and Locations

Study Locations

• Italy
  • Lodi, Italy
    • ASST Lodi
  • Pisa, Italy
    • Azienda ospedaliero-universitaria Pisana,Ospedale Cisanello
  • Pistoia, Italy
    • Ospedale San Jacopo
  • Roma, Italy
    • Policlinico Gemelli
  • Trieste, Italy
    • Ospedale di Cattinara
  • LC
    • Lecco, LC, Italy
      • Ospedale Manzoni
  • MB
    • Monza, MB, Italy, 20900
      • ASST Monza
  • Mi
    • Milano, Mi, Italy
      • Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing emergency surgery for abdominal sepsis or occlusion and treated with bowel resection with or without anastomosis, intestinal bypass or adhesiolysis.

Description

Inclusion Criteria:

• patients undergoing emergency abdominal surgery for abdominal sepsis or occlusion and treated with bowel resection with or without anastomosis, intestinal bypass or adhesiolysis.

Exclusion Criteria:

• age <18
• emergency surgery for post-operative complications of post diagnostic procedures

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study population; All patients undergoing emergency abdominal surgery for infection or occlusion and treated with bowel resection with or without anastomosis; intestinal bypass or adhesiolysis	Other: Application of ERAS protocol; Application of a standardized ERAS protocol for the perioperative perioperative management of patients undergoing emergency surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: % of application of post-operative ERAS items	Compliance to the standardize protocol for each item	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: complications rate within 30 days	Complication rate and mortality	30 days

Collaborators and Investigators

• Sponsor: University of Milano Bicocca
• Investigators: Principal Investigator: Marco Braga, MD, University of Milano Bicocca

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: ERAS in CDU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No