Status:
COMPLETED
Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery
Lead Sponsor:
Fresenius Kabi
Conditions:
Rectal Tumors
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this pilot study is to investigate effectiveness, tolerability and safety of an oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low anterior resection.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00730808
Start Date
December 1 2008
End Date
November 1 2009
Last Update
May 19 2010
Active Locations (1)
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1
Medical Center Alkmaar
Alkmaar, Netherlands