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.

Study Overview

• Status: Unknown
• Conditions: Liver Diseases; Pancreas Disease
• Intervention / Treatment: Procedure: HPB resection

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.

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of functional recovery from surgery	Time to achieve discharge criteria post-operatively	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Post operative complications	90 days
Compliance	Adherence rates to ERAS protocol and individual ERAS components	90 days
Length of Stay	Time in hospital after surgery	90 days

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian

Study record dates

Study Major Dates

• Study Start (Anticipated): February 5, 2019
• Primary Completion (Anticipated): June 5, 2019
• Study Completion (Anticipated): July 5, 2019

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Pancreatic Diseases
• Other Study ID Numbers: 18185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No