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Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery

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ClinicalTrials.gov Identifier: NCT00503334
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : December 8, 2008
Sponsor:
Information provided by:
Fresenius Kabi

Brief Summary:
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 or disease Intervention/treatment Phase
Enteral Nutrition (Food for Special Medical Purposes) Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo in Visceral Surgery
Study Start Date : July 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP; [ Time Frame: up to 30 days after surgery ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective pancreaticoduodenectomy

Exclusion Criteria:

  • Concomitant chemotherapy
  • Severe malnutrition (SGA score C)
  • Conditions affecting gastric emptying

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Steffen Benzing, Fresenius Kabi Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00503334     History of Changes
Other Study ID Numbers: N-POB-03-IT
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: December 8, 2008
Last Verified: November 2008