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Trial Title:
Pre-habilitation to Improve Outcomes in Patients Undergoing Liver Resection for Cancer
NCT ID:
NCT01542281
Condition:
Colorectal Neoplasm
Biliary Tract Neoplasm
Liver Neoplasm
Conditions: Official terms:
Neoplasms
Colorectal Neoplasms
Liver Neoplasms
Biliary Tract Neoplasms
Conditions: Keywords:
liver resection
hepatectomy
pre-habilitation
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Whey protein and dietary supplements
Description:
Whey protein and dietary supplements in addition to pre-hab exercise
Arm group label:
Nutritional supplementation and prehab
Intervention type:
Other
Intervention name:
prehab exercise
Description:
minimum 4 weeks and maximum 8 weeks; 3 times a week
Arm group label:
Prehab exercise
Other name:
weight training , walking, cycling etc.
Summary:
1. To determine whether a combined nutritional support program and exercise-based
prehabilitation is superior to nutritional support alone in increasing functional
recovery and reducing post-operative morbidity after surgery for HPB malignancy.
2. To understand which measures of immediate surgical recovery are sensitive to
prehabilitation interventions and predict change in later outcome measures.
Detailed description:
Patients scheduled for elective liver resection be will be approached andrandomized to
one of two groups using a computer generated block randomisation scheme. The first group
(pre-hab) will receive both nutritional supplementation and a prehabilitation program as
outlined below. The second group (nutrition) will receive only nutritional
supplementation. Both groups will be given a post-operative exercise program.
Once randomized, the subjects will be called by the research co-ordinator and an
appointment will be made for the initial assessment. After the study is explained and
consent obtained, subjects will be tested on 6MWT, followed by a 30 minute rest period
during which various questionnaires assessing physical activity, quality of life, fatigue
and nutritional status will be completed with the aid of the coordinator.
The prehabilitation program will last a minimum of four weeks and a maximum of 8 weeks.
Surgery will be performed by one of the HPB surgeons at the McGill University Health
Center. Surgical approach, including laparoscopic or open surgery will be at the
discretion of the surgeon. Perioperative care will follow an Enhanced Recovery After
Surgery (ERAS)-based clinical care pathway27, 28, a fast-track care plan including
patient education, afferent neural blockade, multimodal analgesia, early oral intake and
mobilization, early removal of catheters and drains, and a planned 6-8 day hospital
admission. This pathway has already been implemented at the Royal Victoria Hospital as
part of standard patient care.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subjects eligible to enter the prehabilitation program will include those aged 18
and above and referred electively for resection of malignancies.
Exclusion Criteria:
- Excluded will be persons with American Society of Anesthesiologists (ASA) health
status class 4-5 or co-morbid medical, physical and mental conditions (e.g.
dementia, disabling orthopedic and neuromuscular disease, psychosis), cardiac
abnormalities, severe end-organ disease such as cardiac failure, COPD, and hepatic
failure (ALT and AST >50% over the normal range), and sepsis), morbid obesity (BMI
>40), anemia (hematocrit < 30 %) and other conditions interfering with the ability
to perform exercise at home or to complete the testing procedures.
- Patients will be excluded if they have poor English or French comprehension.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Royal Victoria Hospital
Address:
City:
Montreal
Zip:
H3A1A1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Ayat Salman, MSccandidate
Phone:
5149341934
Phone ext:
36237
Email:
ayat.salman@muhc.mcgill.ca
Investigator:
Last name:
Prosanto Chaudhury, MD
Email:
Principal Investigator
Start date:
January 2012
Completion date:
January 2015
Lead sponsor:
Agency:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Agency class:
Other
Source:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01542281
