Application of ERAS Protocol in Emergency Surgery

Enhanced Recovery After Surgery Clinical Trial

— ERAS in CDU  

Official title:

Application of ERAS Protocol in Emergency Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648644
• Other study ID #: ERAS in CDU
• Status: Completed
• Start date: November 3, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: June 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency Surgery
• Enhanced Recovery After Surgery

Intervention

Other:
• Application of ERAS protocol
Application of a standardized ERAS protocol for the perioperative perioperative management of patients undergoing emergency surgery

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: % of application of post-operative ERAS items	Compliance to the standardize protocol for each item	30 days
Secondary	Safety: complications rate within 30 days	Complication rate and mortality	30 days