The Effect of Analgesic Modalities on Long Term Outcomes Following Open Liver Resection
NCT ID: NCT03813953
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2019-03-06
2019-08-30
Brief Summary
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The overall findings of this trial were of similar rates of morbidity and pain control post-operatively but a reduced recovery time for the wound catheter group. As a result, wound catheter local anesthetic infiltration has become increasingly utilized in this unit and within other units throughout the country and worldwide.
Epidural use has been associated with improved long term outcomes following abdominal cancer surgery. This study is therefore a long term follow up study of the LIVER and LIVER 2 trials to assess survival between the two groups.
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Detailed Description
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The overall findings of this trial were of similar rates of morbidity and pain control post-operatively but a reduced recovery time for the wound catheter group. As a result, wound catheter local anesthetic infiltration has become increasingly utilized in this unit and within other units throughout the country and worldwide.
There has been some evidence however, that epidural analgesia post-operatively can have a positive impact on long term survival in patients undergoing abdominal surgery for cancer. The reasons for this are not well established but it is proposed that the protective effect against the immunosuppression following major surgery that epidural has can aid in the cancer prevention process. There remains no randomised controlled trials looking at this subject in open liver surgery.
The aim of this study is to assess the overall and disease free survival of the patients who participated in the LIVER and LIVER 2 trials.
The primary outcome is 5 year overall survival. Data will be observed from electronic (or non electronic) patient records, information and statistics department data and general practice records as required.
Overall survival at 1 and 3 years Disease free survival at 1, 3 and 5 years (Data will be observed from Lothian hepatobiliary multi-disciplinary team meeting data and follow up CT/MRI scan dates)
Median overall and disease free survival Survival according to individual pathology subgroups.
Participants will be identified from study records of the LIVER and LIVER 2 trials. This will be performed by the two study investigators.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Local Anaesthetic Wound Infiltration
Wound catheter delivering local anaesthetic for 48 hours post-operatively following liver resection
Liver resection
Resection of diseased liver
Epidural
Conventional practice following liver resection
Liver resection
Resection of diseased liver
Interventions
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Liver resection
Resection of diseased liver
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Edinburgh
OTHER
Responsible Party
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Principal Investigators
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Michael Hughes
Role: PRINCIPAL_INVESTIGATOR
NHS Lothian
Locations
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NHS Lothian
Edinburgh, , United Kingdom
Countries
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Other Identifiers
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258352
Identifier Type: -
Identifier Source: org_study_id
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