ERAS in Liver Surgery (ERASliver)

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

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.

Study Overview

• Status: Completed
• Conditions: ERAS
• Intervention / Treatment: Procedure: Liver resection

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• Italy
  • MB
    • Monza, MB, Italy, 20900
      • Ospedale San Gerardo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

126 patients were consecutively enrolled from January 2019 to July 2021

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ERAS-in; Patients who completed ERAS program	Procedure: Liver resection; Liver resection, different kind of according to pathology
ERAS-out; Patients who dropped-out from ERAS program	Procedure: Liver resection; Liver resection, different kind of according to pathology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance to ERAS program	Compliance to ERAS program was defined as at least 80% of accomplished items per patient	32 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance to ERAS items	Compliance to each ERAS item singularly	32 months
Drop-out factors	Determining factors associated with ERAS program drop-out	32 months

Collaborators and Investigators

• Sponsor: University of Milano Bicocca

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ERASliver

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