ERASERASliverNCT05597319
ERAS in Liver Surgery
An observational study of ERAS, run by University of Milano Bicocca at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ERAS
- What is being tested?
- Liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 126 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 126 patients were consecutively enrolled from January 2019 to July 2021
Who may be able to join
- patients candidates to surgery for benign or malignant liver disease
- liver resection with curative intent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- ERAS
- Being tested
- Liver resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resectionProcedure or surgery
Liver resection, different kind of according to pathology
| Study group | Role | What they receive |
|---|---|---|
| ERAS-in | Patients who completed ERAS program Receives: Procedure: Liver resection | |
| ERAS-out | Patients who dropped-out from ERAS program Receives: Procedure: Liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to ERAS program
Compliance to ERAS program was defined as at least 80% of accomplished items per patient
Measured: 32 months
Secondary outcomes (2)
Compliance to ERAS items
Compliance to each ERAS item singularly
Measured: 32 months
Drop-out factors
Determining factors associated with ERAS program drop-out
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Jan 2019
- Primary completion31 Jul 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERASStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597319
- Sponsor's protocol ID
- ERASliver
- Acronym
- ERASliver
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery: Compliance to the Program in Liver Surgery and Factors Associated With Drop-out
- ClinicalTrials.gov ID
- NCT05597319
- Acronym / sponsor ID
- ERASliver / ERASliver
- Conditions
- ERAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS-in | – | Procedure: Liver resectionPatients who completed ERAS program |
| ERAS-out | – | Procedure: Liver resectionPatients who dropped-out from ERAS program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 126 patients were consecutively enrolled from January 2019 to July 2021
Key inclusion criteria (2 listed)
- patients candidates to surgery for benign or malignant liver disease
- liver resection with curative intent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver resectionLiver resection, different kind of according to pathology | Procedure or surgery | ERAS-in, ERAS-out |
Primary outcome
Compliance to ERAS program
Time frame: 32 months
Compliance to ERAS program was defined as at least 80% of accomplished items per patient
2 secondary outcomes
Compliance to ERAS items
Time frame: 32 months
Drop-out factors
Time frame: 32 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for ERAS
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The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases
mERAS Intervention, The ASA (American Society of Anesthesiologists) Score
Enrolling by invitation
Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of ERAS Based on the Mobile Application
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RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
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Recruiting
Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)
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Post Operative Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ERAS, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to ERAS program (time frame: 32 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.