Oral Versus Parenteral Nutrition Support to Improve Protein Balance in Colorectal Surgical Patients

A prospective, randomized controlled study, using stable isotope methodology, is proposed to determine whether an oral nutrition support regimen, containing pressurized whey protein and glucose, is more effective at normalizing the metabolic response to surgery than a standard peripheral parenteral nutrition (PPN) support regimen, containing amino acids and glucose, in colorectal surgical patients studied before and after surgery. The effectiveness of the nutrition support regimens will be determined by: whole body protein balance, synthesis rates of hepatic secretory proteins, resting energy expenditure and substrate utilization, as well as circulating metabolites concentrations.

• Dietary Supplement: Oral Nutrition with dextrose and pressurized whey protein
  Ten (10) subjects will be randomly assigned to receive an oral nutrition regimen comprised of 50% of their REE as dextrose and 20% of their REE as pressurized whey protein. Subjects will undergo a six-hour stable isotope infusion protocol one day before surgery (to obtain baseline data) and on the first post-operative day. During both infusion protocols, subjects will be asked to carry out their assigned oral nutrition regimen. To minimize fasting during the perioperative period all subjects will receive peripheral parenteral nutrition (PPN) at the time of surgical incision until the first postoperative day.
• Dietary Supplement: Peripheral Parenteral Nutrition
  Ten (10) subjects will be randomly assigned to receive peripheral parenteral nutrition (PPN) regimen comprised of 50% of their REE as dextrose and 20% of their REE as amino acids. Subjects will undergo a six-hour stable isotope infusion protocol one day before surgery (to obtain baseline data) and on the first post-operative day. During both infusion protocols, subjects will be asked to carry out their assigned PPN regimen. To minimize fasting during the perioperative period all subjects will receive PPN at the time of surgical incision until the first postoperative day.

• Active Comparator: Oral Nutrition
  Subjects will receive an oral nutrition regimen comprised of 50% of their Resting Energy Expenditure (REE) as dextrose and 20% of their REE as pressurized whey protein
  Intervention: Dietary Supplement: Oral Nutrition with dextrose and pressurized whey protein
• Placebo Comparator: Peripheral Parenteral Nutrition
  Subjects will receive a peripheral parenteral nutrition (PPN) regimen comprised of 50% of their Resting Energy Expenditure (REE) as dextrose and 20% of their REE as amino acids.
  Intervention: Dietary Supplement: Peripheral Parenteral Nutrition

Inclusion Criteria:

1. The American Society of Anesthesiologists' (ASA) class 1 to 3
2. Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy)
3. Nutrition status: 18.5 < body mass index < 30 kg/m2, stable weight over the preceding three months (< 10% body weight loss), serum albumin > 35g/l

Exclusion Criteria:

1. History of hepatic failure (Child-Pugh score A-C and transaminases outside the normal range)
2. Renal impairment (Serum Creatinine outside normal range)
3. Cardiac failure (New York Heart Association (NYHA) classes I-IV)
4. Hepatic, Renal, Cardiac transplant
5. Endocrine disorders: diabetes type I & II, hyper and hypothyroidism
6. Active inflammatory bowel or diverticular disease (Crohn's Disease, Ulcerative Colitis)
7. Musculoskeletal or neuromuscular disease
8. Anemia defined as hematocrit < 30, hemoglobin < 10 g/dl, albumin < 25 mg/dl
9. Previous spine surgery or scoliosis limiting use of epidural
10. Pregnancy
11. Use of Steroids
12. Milk protein allergy or intolerance

• Montreal General Hospital
• McGill University