ERAS in Liver Surgery

Completed

• Conditions: ERAS
• Interventions: Procedure: Liver resection

• Registration Number: NCT05597319
• Lead Sponsor: University of Milano Bicocca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-09-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-24
• Last Update Submitted: 2022-10-24
• Study First Posted: 2022-10-28
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ERAS-in	Liver resection	Patients who completed ERAS program
ERAS-out	Liver resection	Patients who dropped-out from ERAS program

Primary Outcome Measures

Name	Time	Method
Compliance to ERAS program	32 months	Compliance to ERAS program was defined as at least 80% of accomplished items per patient

Secondary Outcome Measures

Name	Time	Method
Compliance to ERAS items	32 months	Compliance to each ERAS item singularly
Drop-out factors	32 months	Determining factors associated with ERAS program drop-out

Trial Locations

Locations (1)

Ospedale San Gerardo; 🇮🇹 Monza, MB, Italy