Liver Diseases Clinical Trial
Official title:
Enhanced Recovery After Surgery for Hepatobiliary-Pancreatic 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 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.
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.
2. OBJECTIVES
To compare the compliance of ERAS protocol care components within an HPB unit before and
after an education programme.
3. 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.
4. 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.
5. DATA COLLECTION Over a six month period the compliance to the ERAS protocol will be
assessed in patients undergoing HPB resections.
Compliance programme
1. Patients will be given an information leaflet describing their post-operative care
pathway
2. Nursing and medical staff will receive education regarding the ERAS protocol and
achievements
3. Auditing of the ERAS protocol adherence will subsequently be performed
Outcome measures
1. Functional recovery
2. Morbidity
3. Compliance rate of the individual peri-operative care components
4. Drop out rate
5. Length of stay
6. 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.
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