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Sponsored by: |
Fresenius Kabi |
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Information provided by: | Fresenius Kabi |
ClinicalTrials.gov Identifier: | NCT00662376 |
The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.
Condition | Intervention |
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Enteral Nutrition Regimen Prior to Surgery |
Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes) |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety, Tolerance and Metabolic Effects of Using a Preoperative Oral Nutritional Supplement (PreOP Booster) in Gastrointestinal Surgery |
Enrollment: | 40 |
Study Start Date: | April 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Test: Experimental
oral nutritional supplement (assignment: according to consecutive random numbers)
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Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)
3 x 1 dosages of oral nutritional supplement / placebo are given prior to surgery: 2 the evening before the day of operation and 1 dosage 3-4 h before initiation of anaesthesia
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Control: Placebo Comparator
placebo (assignment: according to consecutive random numbers)
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Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)
3 x 1 dosages of oral nutritional supplement / placebo are given prior to surgery: 2 the evening before the day of operation and 1 dosage 3-4 h before initiation of anaesthesia
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals; | |
Nottingham, United Kingdom |
Principal Investigator: | Dileep N. Lobo, MS, DM, FRCS | Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals; |
Responsible Party: | Kabi Innovation Centre, Fresenius Kabi Deutschland GmbH ( Dr. Steffen Benzing ) |
Study ID Numbers: | N-POB-01-UK |
Study First Received: | April 17, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00662376 History of Changes |
Health Authority: | United Kingdom: Ethics commission |
Anesthetics |