Status:
COMPLETED
Oral Versus Parenteral Nutrition Support to Improve Protein Balance in Colorectal Surgical Patients
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Montreal General Hospital
McGill University
Conditions:
Colon Cancer
Eligibility:
All Genders
18-85 years
Phase:
NA
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 mo...
Eligibility Criteria
Inclusion
- The American Society of Anesthesiologists' (ASA) class 1 to 3
- Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy)
- 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
- History of hepatic failure (Child-Pugh score A-C and transaminases outside the normal range)
- Renal impairment (Serum Creatinine outside normal range)
- Cardiac failure (New York Heart Association (NYHA) classes I-IV)
- Hepatic, Renal, Cardiac transplant
- Endocrine disorders: diabetes type I \& II, hyper and hypothyroidism
- Active inflammatory bowel or diverticular disease (Crohn's Disease, Ulcerative Colitis)
- Musculoskeletal or neuromuscular disease
- Anemia defined as hematocrit \< 30, hemoglobin \< 10 g/dl, albumin \< 25 mg/dl
- Previous spine surgery or scoliosis limiting use of epidural
- Pregnancy
- Use of Steroids
- Milk protein allergy or intolerance
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01222208
Start Date
March 1 2011
End Date
November 1 2011
Last Update
February 7 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4