Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery
This study has been completed.
Sponsor:
Fresenius Kabi
Information provided by:
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT00503334
First received: July 16, 2007
Last updated: December 5, 2008
Last verified: November 2008
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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) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo in Visceral Surgery |
Resource links provided by NLM:
Further study details as provided by Fresenius Kabi:
Primary Outcome Measures:
- laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP; [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- postoperative complications, pre- and postoperative discomfort (well-being), muscle strength at 7 days post-op, length of stay (hospital / ICU), ambulation time, gastro intestinal tolerance [ Time Frame: up to 30 days after surgery ] [ Designated as safety issue: No ]
| Enrollment: | 36 |
| Study Start Date: | July 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: preOP booster |
Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)
3x1 dosage pre-operatively
|
| Placebo Comparator: preOP booster placebo |
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 |
Criteria
Inclusion Criteria:
- Elective pancreaticoduodenectomy
Exclusion Criteria:
- Concomitant chemotherapy
- Severe malnutrition (SGA score C)
- Conditions affecting gastric emptying
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503334
Locations
| Italy | |
| Università Salute-Vita San Raffaele, | |
| Milan, Italy, 20132 | |
Sponsors and Collaborators
Fresenius Kabi
Investigators
| Principal Investigator: | Marco Braga, Prof MD | Università Salute-Vita San Raffaele, Milan, Italy |
More Information
No publications provided
| Responsible Party: | Dr. Steffen Benzing, Fresenius Kabi Deutschland GmbH |
| ClinicalTrials.gov Identifier: | NCT00503334 History of Changes |
| Other Study ID Numbers: | N-POB-03-IT |
| Study First Received: | July 16, 2007 |
| Last Updated: | December 5, 2008 |
| Health Authority: | Italy: Ethics Committee |
ClinicalTrials.gov processed this record on June 18, 2013