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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03772392
Other study ID # 18185
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 5, 2019
Est. completion date November 5, 2019

Study information

Verified date January 2019
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 5, 2019
Est. primary completion date June 5, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients undergoing open HPB resectional surgery within the HPB unit at the Royal Infirmary of Edinburgh Exclusion Criteria: - Laparoscopic surgery Non resectional surgery

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
HPB resection
:Liver and Pancreas surgery - Compliance with ERAS protocol

Locations

Country Name City State
United Kingdom NHS Lothian Edinburgh

Sponsors (2)

Lead Sponsor Collaborator
University of Edinburgh NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time of functional recovery from surgery Time to achieve discharge criteria post-operatively 90 days
Secondary Morbidity Post operative complications 90 days
Secondary Compliance Adherence rates to ERAS protocol and individual ERAS components 90 days
Secondary Length of Stay Time in hospital after surgery 90 days
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