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Oral Versus Parenteral Perioperative Nutrition Support to Improve Protein Balance: Stable Isotope Study in Colorectal Surgical Patients


N/A
18 Years
85 Years
Not Enrolling
Both
Colon Cancer

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Trial Information

Oral Versus Parenteral Perioperative Nutrition Support to Improve Protein Balance: Stable Isotope Study in Colorectal Surgical Patients


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Whole body protein balance

Outcome Description:

Whole body protein balance (the difference between protein synthesis and protein breakdown) as assessed by the kinetics of a stable, non-radioactive, isotope tracer infusion of L-[1-13C] leucine

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Franco Carli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

McGill University Health Center

Authority:

Canada: Ethics Review Committee

Study ID:

10-106-GEN

NCT ID:

NCT01222208

Start Date:

March 2011

Completion Date:

November 2011

Related Keywords:

  • Colon Cancer
  • Bowel resection
  • Colonic Neoplasms

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