NCT05597319

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

2.6 years

First QC Date

October 24, 2022

Last Update Submit

October 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Compliance to ERAS program

    Compliance to ERAS program was defined as at least 80% of accomplished items per patient

    32 months

Secondary Outcomes (2)

  • Compliance to ERAS items

    32 months

  • Drop-out factors

    32 months

Study Arms (2)

ERAS-in

Patients who completed ERAS program

Procedure: Liver resection

ERAS-out

Patients who dropped-out from ERAS program

Procedure: Liver resection

Interventions

Liver resection, different kind of according to pathology

ERAS-inERAS-out

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

126 patients were consecutively enrolled from January 2019 to July 2021

You may qualify if:

  • patients candidates to surgery for benign or malignant liver disease
  • liver resection with curative intent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Gerardo

Monza, MB, 20900, Italy

Location

MeSH Terms

Interventions

Hepatectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2022

First Posted

October 28, 2022

Study Start

January 1, 2019

Primary Completion

July 31, 2021

Study Completion

September 30, 2021

Last Updated

October 28, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations