Liver DiseasesNCT03772392
Enhanced Recovery After Surgery for Hepatobiliary-Pancreatic Surgery
An observational study of Liver Diseases and Pancreas Disease, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
ERAS protocols have been utilized extensively in abdominal and non abdominal surgery over the past 20 years. These protocols incorporate evidence based, multi-disciplinary peri-operative care components. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Pancreas Disease
- What is being tested?
- HPB resection
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Feb 2019to 5 Nov 2019
- 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
- Adult, Older adult
Study population: Those patients to be included will be identified from the theatre schedule as listed for HPB resectional surgery. Their compliance with the ERAS protocol will then be observed over the course of their stay.
Who may be able to join
- All patients undergoing open HPB resectional surgery within the HPB unit at the Royal Infirmary of Edinburgh
Who cannot join
- Laparoscopic surgery Non resectional surgery
Trial locations and contacts
1 site in 1 country.
About this study
ERAS protocols have been utilized extensively in abdominal and non abdominal surgery over the past 20 years. These protocols incorporate evidence based, multi-disciplinary peri-operative care components. Compliance with these protocols is associated with reduced length of stay, reduced morbidity and reduced hospital costs.
ERAS protocols within HPB units are les well established with less evidence supporting their use. Liver resection protocols are increasing in use, but ERAS post Whipples resection is less established.
In the HPB unit at the Royal Infirmary of Edinburgh, the liver HPB protocol is in use but a recent audit identified that that the compliance rate is low with compliance rates as low as 30 per cent in some care domains.
Read the detailed description
1.1 Background
Enhanced Recovery After Surgery(ERAS) protocols have been utilized extensively in abdominal and non abdominal surgery over the past 20 years. These protocols incorporate evidence based, multi-disciplinary peri-operative care components. Compliance with these protocols is associated with reduced length of stay, reduced morbidity and reduced hospital costs.
ERAS protocols within hepatobiliary pancreatic (HPB) units are les well established with less evidence supporting their use. Liver resection protocols are increasing in use, but ERAS post Whipples resection is less established.
1.2 RATIONALE FOR STUDY
In the HPB unit at the Royal Infirmary of Edinburgh, the liver HPB protocol is in use but a recent audit identified that that the compliance rate is low with compliance rates as low as 30 per cent in some care domains.
- OBJECTIVES
To compare the compliance of ERAS protocol care components within an HPB unit before and after an education programme.
- STUDY POPULATION
3.1 NUMBER OF PARTICIPANTS An attempt to observe 100 patients will be made over the study period. A preliminary audit of 27 patients has been performed.
- PARICIPANT SELECTION
4.1 IDENTIFYING PARTICIPANTS
Those patients to be included will be identified from the theatre schedule as listed for HPB resectional surgery. Their compliance with the ERAS protocol will then be observed over the course of their stay.
4.2 CONSENT The ERAS protocol is part of the unit policy and so patients will not be undergoing any intervention that is not already part of normal practice and consent. Therefore further or additional consent will not be required.
- DATA COLLECTION Over a six month period the compliance to the ERAS protocol will be assessed in patients undergoing HPB resections.
Compliance programme
- Patients will be given an information leaflet describing their post-operative care pathway
- Nursing and medical staff will receive education regarding the ERAS protocol and achievements
- Auditing of the ERAS protocol adherence will subsequently be performed
Outcome measures
- Functional recovery
- Morbidity
- Compliance rate of the individual peri-operative care components
- Drop out rate
- Length of stay
- STATISTICAL ANALYSIS Chi squared analysis of dichotomised data will be performed. T test and Mann Whitney U tests will be performed to assess differences between the pre and post education programme results.
- Conditions
- Liver Diseases, Pancreas Disease
- Being tested
- HPB resection
- Medical subject headings
- Liver Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPB resectionProcedure or surgery
:Liver and Pancreas surgery - Compliance with ERAS protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of functional recovery from surgery
Time to achieve discharge criteria post-operatively
Measured: 90 days
Secondary outcomes (3)
Morbidity
Post operative complications
Measured: 90 days
Compliance
Adherence rates to ERAS protocol and individual ERAS components
Measured: 90 days
Length of Stay
Time in hospital after surgery
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start5 Feb 2019
- Primary completion5 Jun 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772392
- Sponsor's protocol ID
- 18185
- Status last verified
- Jan 2019
- First submitted
- 10 Dec 2018
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery for Hepatobiliary-Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT03772392
- Acronym / sponsor ID
- 18185
- Conditions
- Liver Diseases, Pancreas Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 11 Dec 2018 (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.
ERAS protocols have been utilized extensively in abdominal and non abdominal surgery over the past 20 years. These protocols incorporate evidence based, multi-disciplinary peri-operative care components. Compliance with these protocols is associated with reduced length of stay, reduced morbidity and reduced hospital costs.
ERAS protocols within HPB units are les well established with less evidence supporting their use. Liver resection protocols are increasing in use, but ERAS post Whipples resection is less established.
In the HPB unit at the Royal Infirmary of Edinburgh, the liver HPB protocol is in use but a recent audit identified that that the compliance rate is low with compliance rates as low as 30 per cent in some care domains.
Detailed description
1.1 Background
Enhanced Recovery After Surgery(ERAS) protocols have been utilized extensively in abdominal and non abdominal surgery over the past 20 years. These protocols incorporate evidence based, multi-disciplinary peri-operative care components. Compliance with these protocols is associated with reduced length of stay, reduced morbidity and reduced hospital costs.
ERAS protocols within hepatobiliary pancreatic (HPB) units are les well established with less evidence supporting their use. Liver resection protocols are increasing in use, but ERAS post Whipples resection is less established.
1.2 RATIONALE FOR STUDY
In the HPB unit at the Royal Infirmary of Edinburgh, the liver HPB protocol is in use but a recent audit identified that that the compliance rate is low with compliance rates as low as 30 per cent in some care domains.
- OBJECTIVES
To compare the compliance of ERAS protocol care components within an HPB unit before and after an education programme.
- STUDY POPULATION
3.1 NUMBER OF PARTICIPANTS An attempt to observe 100 patients will be made over the study period. A preliminary audit of 27 patients has been performed.
- PARICIPANT SELECTION
4.1 IDENTIFYING PARTICIPANTS
Those patients to be included will be identified from the theatre schedule as listed for HPB resectional surgery. Their compliance with the ERAS protocol will then be observed over the course of their stay.
4.2 CONSENT The ERAS protocol is part of the unit policy and so patients will not be undergoing any intervention that is not already part of normal practice and consent. Therefore further or additional consent will not be required.
- DATA COLLECTION Over a six month period the compliance to the ERAS protocol will be assessed in patients undergoing HPB resections.
Compliance programme
- Patients will be given an information leaflet describing their post-operative care pathway
- Nursing and medical staff will receive education regarding the ERAS protocol and achievements
- Auditing of the ERAS protocol adherence will subsequently be performed
Outcome measures
- Functional recovery
- Morbidity
- Compliance rate of the individual peri-operative care components
- Drop out rate
- Length of stay
- STATISTICAL ANALYSIS Chi squared analysis of dichotomised data will be performed. T test and Mann Whitney U tests will be performed to assess differences between the pre and post education programme results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Those patients to be included will be identified from the theatre schedule as listed for HPB resectional surgery. Their compliance with the ERAS protocol will then be observed over the course of their stay.
Key inclusion criteria (1 listed)
- All patients undergoing open HPB resectional surgery within the HPB unit at the Royal Infirmary of Edinburgh
Key exclusion criteria (1 listed)
- Laparoscopic surgery Non resectional 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 |
|---|---|---|
| HPB resection:Liver and Pancreas surgery - Compliance with ERAS protocol | Procedure or surgery | – |
Primary outcome
Time of functional recovery from surgery
Time frame: 90 days
Time to achieve discharge criteria post-operatively
3 secondary outcomes
Morbidity
Time frame: 90 days
Compliance
Time frame: 90 days
Length of Stay
Time frame: 90 days
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 23 May 2024.
- Individual participant dataSharing planned: Undecided
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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 Liver Diseases and Pancreas Disease, run by University of Edinburgh at 1 site in United Kingdom.
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 1 inclusion and 1 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 23 May 2024. 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 United Kingdom. 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?
Time of functional recovery from surgery (time frame: 90 days). 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 23 May 2024.