ERAS in Liver Surgery

ERAS Clinical Trial

— ERASliver  

Official title:

Enhanced Recovery After Surgery: Compliance to the Program in Liver Surgery and Factors Associated With Drop-out

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05597319
• Other study ID #: ERASliver
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2022
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Enhanced Recovery After Surgery (ERAS) Program (EP) is widely applied to obtain a reduction in post-operative length of hospital stay and a faster restoration of pre-operative patient conditions. However, in Western countries, adherence to EP in liver surgery is still difficult to achieve due to deep-rooted traditional practices. In our Institute, since 2019, EP has been applied pursuing 18/23 items identified by 2016 guidelines. At all consecutive patients who underwent elective liver surgery in our Institution, EP was proposed and their adherence to ERAS items was measured before, during and after surgery. Data were retrospectively collected and analysed, particularly focusing on EP items. Primary outcome was compliance to EP, defined as at least 80% of accomplished items per patient. Secondary outcome was adherence to each ERAS item, while tertiary outcome was detecting the variables associated with program drop out.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 30, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients candidates to surgery for benign or malignant liver disease

• liver resection with curative intent

Exclusion Criteria:

• refusal to participate at the EP

• incapability to acquire informed consent

• cognitive impairment that can prejudice the patient comprehension of the EP

• liver surgery with palliative or diagnostic intent or non-resective liver surgery

• emergency surgery

Related Conditions & MeSH terms

• ERAS

Intervention

Procedure:
• Liver resection
Liver resection, different kind of according to pathology

Locations

Country	Name	City	State
Italy	Ospedale San Gerardo	Monza	MB

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	Compliance to ERAS program	Compliance to ERAS program was defined as at least 80% of accomplished items per patient	32 months
Secondary	Compliance to ERAS items	Compliance to each ERAS item singularly	32 months
Secondary	Drop-out factors	Determining factors associated with ERAS program drop-out	32 months