Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery - Full Text View

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

U.S. FDA Resources

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

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 ]

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

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

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

ClinicalTrials.gov processed this record on August 20, 2008

Sponsored by:	Fresenius Kabi
Information provided by:	Fresenius Kabi
ClinicalTrials.gov Identifier:	NCT00503334