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Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity


N/A
18 Years
85 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity


The aims of this research project are the following:

1. Determine to what extent a nutritional prehabilitation regimen, which includes whey
protein, initiated before surgery and continued after surgery, optimizes the recovery
of functional walking capacity following colorectal resection for cancer.

2. To understand further which measures of immediate surgical recovery are sensitive to
prehabilitation interventions, and predict change in later outcome measures.


Inclusion Criteria:



- +18 years of age

- referred electively for resection of malignant, non metastasized, colorectal lesions

- French or English speaking

Exclusion Criteria:

- ASA class 4-5

- 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 (New York Heart Association classes
I-IV), COPD, renal failure (creatinine > 1.5 mg/dl, and hepatic failure ALT and AST
>50% over the normal range)

- sepsis

- morbid obesity (BMI >40)

- anemia (hematocrit < 30 %, haemoglobin <10g/dl, albumin < 25mg/dl).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Six-Minute Walk Test (6MWT)

Outcome Description:

Change in functional walking capacity will be assessed throughout the study according to the 6-Minute Walk Test (6MWT). The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines.

Outcome Time Frame:

up to 8 weeks after surgery

Safety Issue:

No

Principal Investigator

Franco Carli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

McGill University Health Center

Authority:

Canada: Ethics Review Committee

Study ID:

11-240-SDR

NCT ID:

NCT01727570

Start Date:

September 2012

Completion Date:

December 2013

Related Keywords:

  • Colorectal Cancer
  • Cancer
  • Colon
  • Rectum
  • Surgery
  • Colorectal Neoplasms

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