NCT03772392

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 5, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2019

Completed
Last Updated

May 23, 2024

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

December 10, 2018

Last Update Submit

May 22, 2024

Conditions

Liver DiseasesPancreas Disease

Outcome Measures

Primary Outcomes (1)

  • Time of functional recovery from surgery

    Time to achieve discharge criteria post-operatively

    90 days

Secondary Outcomes (3)

  • Morbidity

    90 days

  • Compliance

    90 days

  • Length of Stay

    90 days

Interventions

HPB resectionPROCEDURE

:Liver and Pancreas surgery - Compliance with ERAS protocol

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patients undergoing open HPB resectional surgery within the HPB unit at the Royal Infirmary of Edinburgh

You may not qualify if:

  • Laparoscopic surgery Non resectional surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Liver DiseasesPancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 11, 2018

Study Start

February 5, 2019

Primary Completion

June 5, 2019

Study Completion

November 5, 2019

Last Updated

May 23, 2024

Record last verified: 2019-01

Locations

GB(1)