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Enhanced Recovery After Surgery for Hepatobiliary-Pancreatic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772392
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

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.


Condition or disease Intervention/treatment
Liver Diseases Pancreas Disease Procedure: HPB resection

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enhanced Recovery After Surgery for Hepatobiliary-Pancreatic Surgery
Estimated Study Start Date : February 5, 2019
Estimated Primary Completion Date : June 5, 2019
Estimated Study Completion Date : July 5, 2019

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


Primary Outcome Measures :
  1. Time of functional recovery from surgery [ Time Frame: 90 days ]
    Time to achieve discharge criteria post-operatively


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 90 days ]
    Post operative complications

  2. Compliance [ Time Frame: 90 days ]
    Adherence rates to ERAS protocol and individual ERAS components

  3. Length of Stay [ Time Frame: 90 days ]
    Time in hospital after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772392


Contacts
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Contact: Michael J Hughes 07734429759 michaelh@doctors.net.uk

Sponsors and Collaborators
University of Edinburgh
NHS Lothian
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03772392    
Other Study ID Numbers: 18185
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Pancreatic Diseases
Digestive System Diseases