NCT01542281

Pre-habilitation to Improve Outcomes in Patients Undergoing Liver Resection for Cancer

Improving Outcomes in Patients With Hepatobiliary Cancers With a Nutritional and Physical Conditioning Pre-habilitation Program

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasm
• Biliary Tract Neoplasm
• Liver Neoplasm

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Whey protein and dietary supplements	Whey protein and dietary supplements in addition to pre-hab exercise
OTHER	prehab exercise	minimum 4 weeks and maximum 8 weeks; 3 times a week

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-01-01
• Completion: 2015-01-01
• First posted: 2012-03-02
• Last updated: 2012-03-02

Locations

1 site across 1 country: Canada