Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (PreOP Booster) vs. Placebo in Surgical Patients (Pilot Study)
N/A
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Rectal Tumors
Both
Rectal Tumors
Trial Information
Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (PreOP Booster) vs. Placebo in Surgical Patients (Pilot Study)
Inclusion Criteria:
- rectal tumour with indication for elective low anterior resection (open surgery, not
laparoscopic surgery) or abdominoperineal resection (APR)
- preoperative radiotherapy (5x5 Gy) or chemoradiation
- loop ileostoma or colostoma;
Exclusion Criteria:
- severe malnutrition
- severe renal insufficiency
- diabetes mellitus I or II
- concomitant thyroid medication
- corticosteroids
- diuretic medication and antihypertensive medication
- known or suspected allergy to any component of the investigational product(s)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Immunoinflammatory parameters
Outcome Time Frame:
on day -2, -1, 1, 2, 3, 5, and 7
Safety Issue:
No
Principal Investigator
Paul A.M. van Leeuwen, Prof.
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Amsterdam; The Netherlands
Authority:
Netherlands: Medical Ethics Review Committee (METC)
Study ID:
N-POB-04-NL
NCT ID:
NCT00730808
Start Date:
December 2008
Completion Date:
November 2009
Related Keywords:
- Rectal Tumors
- Enteral nutritional regimen prior to surgery
- Rectal Neoplasms
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