Clinical trial NCT01222208: Oral Versus Parenteral Nutrition Support to Improve Protein Balance in Colorectal Surgical Patients
Official title: Oral Versus Parenteral Perioperative Nutrition Support to Improve Protein Balance: Stable Isotope Study in Colorectal Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: Bowel resection
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Montreal General Hospital
name: McGill University
First posted: 2010-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Whole body protein balance
timeFrame: 1 year
Secondary outcomes:
measure: Synthesis rates of hepatic secretory proteins
timeFrame: 1 year
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Franco Carli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schricker T, Meterissian S, Lattermann R, Adegoke OA, Marliss EB, Mazza L, Eberhart L, Carli F, Nitschman E, Wykes L. Anticatabolic effects of avoiding preoperative fasting by intravenous hypocaloric nutrition: a randomized clinical trial. Ann Surg. 2008 Dec;248(6):1051-9. doi: 10.1097/SLA.0b013e31818842d8.