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OpenTrials
Completed

NCT Number: NCT05597319

ERAS in Liver Surgery

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.

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Key information

Conditions

ERAS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale San Gerardo

Monza, MB, 20900, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liver resection

Procedure

Liver resection, different kind of according to pathology

Primary outcomes

  1. Compliance to ERAS program

    Time frame: 32 months

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

Secondary outcomes

  1. Compliance to ERAS items

    Time frame: 32 months

    Compliance to each ERAS item singularly

  2. Drop-out factors

    Time frame: 32 months

    Determining factors associated with ERAS program drop-out

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Official study title

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

Acronym: ERASliver

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2022
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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