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| Sponsored by: |
Fresenius Kabi |
| Information provided by: | Fresenius Kabi |
| ClinicalTrials.gov Identifier: | NCT00503334 |
Purpose
The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy.
| Condition | Intervention |
|
Enteral Nutrition (Food for Special Medical Purposes) |
Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes) |
| MedlinePlus related topics: | Dietary Supplements |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Official Title: | Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo in Visceral Surgery |
| Estimated Enrollment: | 36 |
| Study Start Date: | July 2007 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| preOP booster: Experimental |
Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)
3x1 dosage pre-operatively
|
| preOP booster placebo: Placebo Comparator |
Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)
3x1 dosage pre-operatively
|
Eligibility
| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |||||
| Università Salute-Vita San Raffaele, | |||||
| Milan, Italy, 20132 | |||||
| Fresenius Kabi |
| Principal Investigator: | Marco Braga, Prof MD | Università Salute-Vita San Raffaele, Milan, Italy |
More Information
| Responsible Party: | Fresenius Kabi Deutschland GmbH ( Dr. Steffen Benzing ) |
| Study ID Numbers: | N-POB-03-IT |
| First Received: | July 16, 2007 |
| Last Updated: | June 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00503334 |
| Health Authority: | Italy: Ethics Committee |