Energy Expenditure and Regeneration Following Liver Resection Resection
EAGLE
The Effect of Liver Regeneration on Resting Energy Expenditure After Liver Resectional Surgery
2 other identifiers
observational
28
1 country
1
Brief Summary
This observational study will measure resting energy expenditure in patients who have undergone liver resection and compare methods of measuring resting energy expenditure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedFirst Posted
Study publicly available on registry
January 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedOctober 16, 2014
October 1, 2014
8 months
November 21, 2013
October 15, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Resting Energy Expenditure (Kcal) following liver resection
2 weeks pre-operatively and post-operative days 3,5 and 7
Secondary Outcomes (1)
Change in total energy expenditure (Kcal) following liver resection
2 weeks pre-operatively and post-operative days 3,5 and 7
Other Outcomes (4)
Volume of liver resected (g)
Post operative day 1
Resting energy expenditure (REE) (Kcal)
4 weeks post-operative
Post-operative blood tests (FBC, U&E, LFT, Coag)
Post-operative days 1-7
- +1 more other outcomes
Study Arms (2)
Major resection
Patients undergoing resection of \>3 segments (resting energy expenditure measured by Sense Wear Armband and indirect calorimetry)
Minor resection
Patients undergoing resection of \</= 3 segments (resting energy expenditure measured by Sense Wear Armband and indirect calorimetry)
Interventions
Observational methods of measuring resting energy expenditure
Eligibility Criteria
Patients undergoing hepatic resection for benign or malignant neoplasms.
You may qualify if:
- Patients undergoing liver resection for benign or malignant hepatic neoplasm
You may not qualify if:
- Inability to give written, informed consent.
- Jaundice (Bilirubin \> 100 μmol/L)
- Liver resection combined with secondary surgical procedure.
- Age \< 18 years
- Pregnant women
- Unable to tolerate either measuring device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- Royal College of Surgeons of Edinburghcollaborator
Study Sites (1)
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Michael j Hughes
University of Edinburgh
- STUDY DIRECTOR
Stephen J Wigmore
University of Edinburgh
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2013
First Posted
January 9, 2014
Study Start
January 1, 2014
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
October 16, 2014
Record last verified: 2014-10